Reported Reactions

Devices › Dc-defibrillator, low-energy, (including paddles)

Device brand name · External dc defibrillator/cardiac monitor

Lifepak 9 Defibrillator/Monitor: medical device reports filed with FDA

264 reports name it, 1996–2011. Manufacturer given most often on reports: Physio-Control. Product code LDD.

264
device reports naming the brand
0% of all MAUDE reports · about 9 a year
0
reports, 12 months to August 2026
0 in the 12 months before
93.9%
classified as malfunction
89.2% across the product code
5.7%
classified as death, as reported
15 reports · not verified by FDA

264 medical device reports received by FDA name the brand "Lifepak 9 Defibrillator/Monitor" (external dc defibrillator/cardiac monitor); the manufacturer given most often on reports is Physio-Control; received from October 1996 to October 2011. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (93.9%), death (5.7%) and injury (0.4%); across all dc-defibrillator, low-energy, (including paddles) reports (product code LDD) death is recorded in 5.7% and malfunction in 89.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to charge (27.7%), failure to deliver energy (22.7%) and failure to discharge (9.5%). The patient problems coded most often are no patient involvement, death and resuscitation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Lifepak 9 Defibrillator/Monitor was received in the five years to August 2026; the latest was received in October 2011.

By year received

039771996: 719961997: 221998: 2019981999: 262000: 920002001: 182002: 420022003: 82005: 420052007: 62008: 7720082009: 462010: 1220102011: 5

Event type and report source

Event type, as classified on the report

Death5.7%15
Injury0.4%1
Malfunction93.9%248
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.6%263
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.4%1

Grey bar: all 16,581 reports carrying product code LDD. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to charge7327.7%8.6%
Failure to deliver energy6022.7%5.8%
Failure to discharge259.5%7.7%
Replace238.7%11.5%
Failure to power up166.1%8.3%
Device displays incorrect message155.7%12.3%
Device inoperablethe device could not be used124.5%5.5%
Loss of powerthe device lost power124.5%4.8%
Energy output problem93.4%1.3%
Failure to run on ac/dc93.4%6.1%
Display or visual feedback problem83%2.8%
Defibrillation/stimulation problem62.3%3.3%
Failure to deliver shock/stimulation62.3%1.2%
Delayed charge time41.5%0.2%
Difficult or delayed activation41.5%0.1%
Malfunction41.5%0.7%
Ekg/ECG analysis, failure to perform31.1%1%
Failure to convert rhythm31.1%0.4%
Other (for use when an appropriate device code cannot be identified)31.1%3%
Battery failure20.8%1.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
No patient involvement11142%
Deaththe patient died; cause not stated by this term228.3%
Resuscitation134.9%
Therapy/non-surgical treatment/delayed/prolonged62.3%
Cardiopulmonary arrest20.8%
Shockshock, a collapse of the circulation20.8%
Arrhythmia10.4%
Burn(s)a burn10.4%
Cardiac arrestthe heart stopped10.4%
Electric shockan electric shock10.4%
Hospitalization required10.4%
Rupturethe device burst10.4%
Surgical procedure, additional10.4%
Therapy/non-surgical treatment, additional10.4%
Treatment with medication(s)10.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureLifepak 9 Defibrillator/MonitorProduct code LDDAll MAUDE reports
Reports26416,58126,136,888
Share of that pool—1.6%0%
Classified as death, per 1,000 reports57579
Classified as injury0.4%2.7%36.2%
Classified as malfunction93.9%89.2%62.3%
Filed by the manufacturer99.6%92.7%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code LDD

BrandReportsLatest 12 monthsClassified as death
Lifepak 20 Defibrillator/Monitor2,75310.8%
Lifepak 12 Defibrillator/Monitor Series3,60804.9%
Pd1400 Defibrillator/Pacemaker1,77706.1%
Pd1200 Defibrillator/Pacemaker1,38004.9%
Lifepak R 20 Defibrillator/Monitor2,24840.5%
Lifepak 10 Defibrillator/Monitor/Pacemaker62204.7%
Lifepak 9p Defibrillator/Monitor/Pacemaker62802.9%
Codemaster Xl42702.1%
Autoclavable Internal Handles Mseries37910.5%
Tempus LS-Manual28586.3%
Heartstart Mrx18,59200.7%
Codemaster Xl+25102.8%
D900 Defibrillator21503.3%
Lifepak 11 Diagnostic Cardiac Monitor21002.4%
Codemaster 10019805.1%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Lifepak 9 Defibrillator/Monitor reports

How many FDA reports name Lifepak 9 Defibrillator/Monitor?

264 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (93.9%), death (5.7%) and injury (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to charge (27.7%), failure to deliver energy (22.7%), failure to discharge (9.5%), replace (8.7%) and failure to power up (6.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Lifepak 9 Defibrillator/Monitor was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.