Welch Allyn, Inc. 901058 (REF 71WT-B)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Nonin SpO2, SureTemp Plus Thermometer · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00732094210408), received between Dec 30, 2019 and Mar 9, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fire” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Fire2
- Battery Problem1
- Overheating of Device1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2023Fire; Overheating of Device; Fire; Overheating of Device
THE CUSTOMER REPORTED THE BACK OF THE CSM UNIT EXPLODED; HOWEVER, AFTER FURTHER INSPECTION IT WAS DETERMINED THAT THE DEVICE DID NOT EXPLODE, BUT THE BATTERY BURNED. THERE WAS NO REPORTED INJURY. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511754 ↗MalfunctionOct 20, 2022Sparking; Sparking
IT WAS REPORTED THAT THE DEVICE SPARKED AND THEN STOPPED WORKING. IT WAS ALSO STATED THAT IT WOULDN'T POWER ON, AND IT HADN'T BEEN USED IN A WHILE. THERE WAS NO REPORT OF USER OR PATIENT INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15637600 ↗MalfunctionDec 30, 2019Fire; Battery Problem; Fire; Battery Problem
WELCH ALLYN RECEIVED A REPORT FROM THE ACCOUNT STATING THE CSM DEVICE CAUGHT FIRE WHILE THE DEVICE WAS CHARGING AND NOT IN USE. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9532431 ↗
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- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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