Spectrum Wireless Battery 36010Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00085412718378), received between May 31, 2021 and Apr 8, 2026 — classified as 2 deaths, 32 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K251636); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Failure to Run on Battery

  IT WAS REPORTED THAT A V9 WIRELESS BATTERY MODULE FAILED DURING USE WITHOUT A NOTIFICATION. THIS WAS FURTHER DESCRIBED AS "THE PUMP STOPPED PUMPING AND THE SCREEN FLICKERED WHITE". THIS OCCURRED DURING PATIENT INFUSION IN THE INTENSIVE CARE UNIT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821571 ↗
• MalfunctionNov 5, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A SPECTRUM V9 WIRELESS BATTERY HAD A DEAD BATTERY DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482225 ↗
• MalfunctionAug 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT A WIRELESS BATTERY MODULE SHUT OFF BY ITSELF DURING PATIENT INFUSION IN THE EMERGENCY DEPARTMENT. THIS PUMP WAS LEFT PLUGGED IN AND DELIVERING MEDICINE ON A PATIENT IN A ROOM. STAFF NOTICED THE IV PUMP TO BE OFF. IT DID NOT ALARM INFUSION COMPLETE OR ANYTHING ELSE- IT WAS JUST OFF. NURSE THEN TURNED THE PUMP BACK ON AND SAW AN ¿IMPROPER SHUTDOWN MESSAGE". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796721 ↗
• MalfunctionDec 17, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT A SPECTRUM V9 WIRELESS BATTERY MODULE OVER HEATED. THIS OCCURRED DURING TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20954028 ↗
• MalfunctionDec 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A SPECTRUM WIRELESS MODULE WAS OVERHEAT ED OCCURRED IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20951954 ↗
• DeathOct 4, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED A SPECTRUM PUMP STOPPED INFUSING AND "DIED" WITHOUT ALARMING A LOW BATTERY. DURING TRANSPORT FROM THE INTENSIVE CARE UNIT TO COMPUTED TOMOGRAPHY (CT) SCAN, THE PATIENT WAS RECEIVING EPINEPHRINE (DOSE, PROGRAMMED VOLUME AND DELIVERY RATE UNKNOWN) AND LACTATED RINGERS VIA A SECOND SPECTRUM PUMP. WHILE EN ROUTE THE PUMP ¿STOPPED WORKING¿ AND THE STAFF WAS UNAWARE OF THIS STOPPAGE AND ¿IT¿S POSSIBLE (THAT THE) NOTICE WAS GIVEN THAT THE BATTERY WAS FAILING BUT DUE TO THE STRESS OF THE SITUATION SOMEONE COULD HAVE IGNORED THE ALARM¿. AT THIS POINT THE PUMP HAD BEEN IN USE FOR ¿TWO PLUS HOURS¿. DOSES OF EPINEPHRINE WERE ¿PUSHED¿, AND A NEW PUMP WAS PROGRAMED TO CONTINUE THE INFUSION. AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT DIED. IT WAS NOT REPORTED WHAT WAS THE CAUSE OF DEATH NOR WAS IT REPORTED IF AN AUTOPSY HAD BEEN REQUESTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20369599 ↗
• DeathOct 4, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED A SPECTRUM PUMP STOPPED INFUSING AND "DIED" WITHOUT ALARMING A LOW BATTERY. DURING TRANSPORT FROM THE INTENSIVE CARE UNIT TO COMPUTED TOMOGRAPHY (CT) SCAN, THE PATIENT WAS RECEIVING LACTATED RINGERS (DOSE, PROGRAMMED VOLUME AND DELIVERY RATE UNKNOWN) AND EPINEPHRINE VIA A SECOND SPECTRUM PUMP. WHILE EN ROUTE THE PUMP "STOPPED WORKING" AND THE STAFF WAS UNAWARE OF THIS STOPPAGE AND "IT'S POSSIBLE (THAT THE) NOTICE WAS GIVEN THAT THE BATTERY WAS FAILING BUT DUE TO THE STRESS OF THE SITUATION SOMEONE COULD HAVE IGNORED THE ALARM". AT THIS POINT THE PUMP HAD BEEN IN USE FOR "TWO PLUS HOURS". AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT DIED. IT WAS NOT REPORTED WHAT WAS THE CAUSE OF DEATH NOR WAS IT REPORTED IF AN AUTOPSY HAD BEEN REQUESTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20369431 ↗
• MalfunctionJun 27, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT A SPECTRUM WIRELESS MODULE HAD IMPROPER SHUTDOWN DURING TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623969 ↗
• MalfunctionMar 18, 2024Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT A SPECTRUM WIRELESS BATTERY MODULE POWERED OFF WITHOUT USER INPUT. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP IN THE CRITICAL CARE AREA. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923525 ↗
• MalfunctionFeb 22, 2024Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT A SPECTRUM WIRELESS BATTERY MODULE WAS CONNECTED TO A PUMP WHICH SHUT OFF UNEXPECTEDLY DURING NOREPINEPHRINE THERAPY IN THE INTENSIVE CARE UNIT. AS A RESULT THE PUMP HAD TO BE REPLACED AND DURING THIS TIME THE PATIENT BECAME HYPOTENSIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18759648 ↗
• MalfunctionFeb 16, 2024Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT A V9 WIRELESS BATTERY FAILED DURING DELIVERY AND THE PUMP SHUT OFF IN INTENSIVE CARE UNIT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719089 ↗
• MalfunctionJan 8, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT A SPECTRUM WIRELESS BATTERY MODULE DID NOT WORK DURING TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472229 ↗
• MalfunctionJan 8, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT A SPECTRUM WIRELESS BATTERY MODULE DID NOT WORK. THIS OCCURRED DURING TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472228 ↗
• MalfunctionJan 8, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT A SPECTRUM V9 WIRELESS BATTERY MODULE INTERNAL POWER SUPPLY DID NOT WORK. THIS OCCURRED DURING TESTING IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472222 ↗
• MalfunctionDec 18, 2023Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT A SPECTRUM WIRELESS MODULE BATTERY DIED WITHIN TWO HOURS OF BEING UNPLUGGED DURING PATIENT INFUSION IN AN AMBULANCE DURING PATIENT TRANSPORT (DELIVERY). THE PATIENT WASN'T TRANSFERRED SUCCESSFULLY AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352428 ↗
• MalfunctionDec 18, 2023Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT A SPECTRUM WIRELESS MODULE BATTERY DIED WITHIN TWO HOURS OF BEING UNPLUGGED DURING PATIENT INFUSION IN AN AMBULANCE DURING PATIENT TRANSPORT (DELIVERY). THE PATIENT WASN'T TRANSFERRED SUCCESSFULLY AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352372 ↗
• MalfunctionDec 18, 2023Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT A SPECTRUM WIRELESS MODULE BATTERY DIED WITHIN TWO HOURS OF BEING UNPLUGGED DURING PATIENT INFUSION IN AN AMBULANCE DURING PATIENT TRANSPORT (DELIVERY). THE PATIENT WASN'T TRANSFERRED SUCCESSFULLY AND IT WAS UNKNOWN IF THERE WAS PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347682 ↗
• MalfunctionNov 17, 2023Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A SPECTRUM WIRELESS MODULE WAS NOT RECEIVING PUMP RUN MESSAGE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165866 ↗
• MalfunctionNov 17, 2023Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT A SPECTRUM IQ INFUSION PUMP NOT RECEIVING PUMP RUN MESSAGE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165731 ↗
• MalfunctionNov 16, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED "A34831, H0629 CORRECTIVE ACTION". THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155688 ↗
• MalfunctionSep 1, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT A SPECTRUM WIRELESS BATTERY MODULE SHUT DOWN AFTER POWER UP AT THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670995 ↗
• MalfunctionAug 28, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT A SPECTRUM IQ PUMP SHUT DOWN AND DID NOT FUNCTION AFTER A RED ALERT. THIS OCCURRED DURING PREVENTIVE MAINTENANCE TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631124 ↗
• MalfunctionJul 24, 2023Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT A SPECTRUM V9 WIRELESS BATTERY CAUSED BATTERY ERROR TO DISPLAY ON THE PUMP DURING NORMAL SALINE THERAPY AT 35 CC BOLUS IN THE EMERGENCY ROOM. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375822 ↗
• MalfunctionMay 12, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT A SPECTRUM V9 WIRELESS BATTERY HAD A VERY LOW BATTERY ERROR ON MULTIPLE PUMPS AND POWER SUPPLIES DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919524 ↗
• MalfunctionApr 20, 2023Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A SPECTRUM V9 WIRELESS BATTERY MODULE SHUTS DOWN BY ITSELF DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775509 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K251636. One submission often covers many models, so check the product and lot details in each record.

• Z-1368-2026 · Jan 13, 2026 · Open, Classified
  Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A