Reported Reactions

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

Device brand name · Portable defib/mon

Codemaster 100: medical device reports filed with FDA

198 reports name it, 2000–2014. Manufacturer given most often on reports: Agilent Technologies. Product code LDD.

198
device reports naming the brand
0% of all MAUDE reports · about 7 a year
0
reports, 12 months to August 2026
0 in the 12 months before
93.4%
classified as malfunction
89.2% across the product code
5.1%
classified as death, as reported
10 reports · not verified by FDA

198 medical device reports received by FDA name the brand "Codemaster 100" (portable defib/mon); the manufacturer given most often on reports is Agilent Technologies; received from January 2000 to November 2014. 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 (93.4%), death (5.1%) and other (1.5%); 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 cable, defective (33.3%), device displays incorrect message (14.6%) and failure to read input signal (8.1%). The patient problems coded most often are death, apnea and asphyxia, fetal. 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 Codemaster 100 was received in the five years to August 2026; the latest was received in November 2014.

By year received

0651292000: 12920002001: 5520012002: 320022011: 420112013: 420132014: 32014

Event type and report source

Event type, as classified on the report

Death5.1%10
Injury0%0
Malfunction93.4%185
Other1.5%3
Not given0%0

Who filed the report

Manufacturer report99.5%197
Voluntary report0.5%1
User facility report0%0
Distributor report0%0
Not given0%0

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
Cable, defective6633.3%1%
Device displays incorrect message2914.6%12.3%
Failure to read input signal168.1%0.5%
Mechanical problema mechanical problem147.1%0.3%
Low battery115.6%0.5%
Device issuea problem with the device94.5%3.2%
Failure to power up94.5%8.3%
Loss of powerthe device lost power94.5%4.8%
No display/image94.5%6.3%
Pacing problem94.5%6.6%
Failure, intermittent84%2.6%
Kinkedthe tube or line kinked84%0%
Battery failure63%1.1%
Replace52.5%11.5%
Defibrillation/stimulation problem42%3.3%
Device inoperablethe device could not be used42%5.5%
Monitor failure42%0.4%
Defective component31.5%0.5%
Failure to deliver energy31.5%5.8%
Image display error/artifact31.5%0.2%

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
Deaththe patient died; cause not stated by this term42%
Apnea10.5%
Asphyxia, fetal10.5%
Cardiac arrestthe heart stopped10.5%
Cardiopulmonary arrest10.5%
Hospitalization required10.5%
Loss of pulse10.5%
Other (for use when an appropriate patient code cannot be identified)10.5%
Therapy/non-surgical treatment, additional10.5%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers10.5%

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

In context

MeasureCodemaster 100Product code LDDAll MAUDE reports
Reports19816,58126,136,888
Share of that pool—1.2%0%
Classified as death, per 1,000 reports51579
Classified as injury0%2.7%36.2%
Classified as malfunction93.4%89.2%62.3%
Filed by the manufacturer99.5%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%
Lifepak 9 Defibrillator/Monitor26405.7%
Heartstart Mrx18,59200.7%
Codemaster Xl+25102.8%
D900 Defibrillator21503.3%
Lifepak 11 Diagnostic Cardiac Monitor21002.4%

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 Codemaster 100 reports

How many FDA reports name Codemaster 100?

198 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 (93.4%), death (5.1%) and other (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

cable, defective (33.3%), device displays incorrect message (14.6%), failure to read input signal (8.1%), mechanical problem (7.1%) and low battery (5.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Codemaster 100 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.