Reported Reactions

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Device brand name · Wireless battery

Wireless Battery Module G: medical device reports filed with FDA

448 reports name it, 2012–2016. Manufacturer given most often on reports: Baxter Healthcare. Product code FRN.

448
device reports naming the brand
0% of all MAUDE reports · about 32 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99.1%
classified as malfunction
98.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

448 medical device reports received by FDA name the brand "Wireless Battery Module G" (wireless battery); the manufacturer given most often on reports is Baxter Healthcare; received from September 2012 to November 2016. 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 (99.1%) and injury (0.2%); across all pump, infusion reports (product code FRN) death is recorded in 0.1% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are moisture damage (21%), moisture or humidity problem (18.1%) and connection problem (11.8%). The patient problems coded most often are no patient involvement, chest tightness/pressure and dyspnea. 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 Wireless Battery Module G was received in the five years to August 2026; the latest was received in November 2016.

By year received

01122242012: 620122013: 12420132014: 22420142015: 7120152016: 232016

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.2%1
Malfunction99.1%444
Other0%0
Not given0.7%3

Who filed the report

Manufacturer report100%448
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 1,831,109 reports carrying product code FRN. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Moisture damage9421%0%
Moisture or humidity problem8118.1%0%
Connection problema connection problem5311.8%0.1%
Thermal decomposition of device419.2%0.1%
Fluid/blood leak368%0.6%
Device operates differently than expectedthe device behaved unexpectedly235.1%0.9%
Corrodedthe device corroded214.7%11.6%
Device displays incorrect message214.7%9.3%
Battery problema problem with the battery194.2%1.2%
Loss of powerthe device lost power184%0.1%
Breakthe device broke153.3%8.5%
Device emits odor143.1%0%
Overheating of device61.3%0%
Improper or incorrect procedure or method51.1%0.1%
Melted51.1%0%
Self-activation or keying51.1%0.1%
Temperature problem51.1%0%
Communication or transmission problemthe device could not communicate or transmit40.9%0.5%
Smoking40.9%0%
Device stops intermittentlythe device stopped now and then30.7%0%

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 involvement16737.3%
Chest tightness/pressure10.2%
Dyspneashortness of breath10.2%
Palpitationsawareness of the heartbeat10.2%

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

In context

MeasureWireless Battery Module GProduct code FRNAll MAUDE reports
Reports4481,831,10926,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports019
Classified as injury0.2%1.3%36.2%
Classified as malfunction99.1%98.5%62.3%
Filed by the manufacturer100%99.1%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 FRN

BrandReportsLatest 12 monthsClassified as death
Alaris Pump Module684,52200%
Alaris System422,50133,6920%
8100 Alaris Pump Module163,62000%
Spectrum Infusion Pump147,363150%
8015 Alaris System Pc Unit54,16200%
Alaris System Pc Unit24,06600%
8110 Alaris Syringe Pump22,43400%
Colleague21,76300%
Reservoir 3ML MMT-332A19,9142,0080.4%
Reservoir 3ml16,40700.8%
Flogard15,66800%
Colleague Volumetric Infusion Pump13,67800.1%
Colleague Pre P1 713,10300%
CADD-Solis VIP Ambulatory Infusion Pump11,7213,4710.1%
Intermate8,261470%

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 Wireless Battery Module G reports

How many FDA reports name Wireless Battery Module G?

448 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 (99.1%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

moisture damage (21%), moisture or humidity problem (18.1%), connection problem (11.8%), thermal decomposition of device (9.2%) and fluid/blood leak (8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Wireless Battery Module G 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.