Welch Allyn, Inc. 901058 (REF 75RE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00732094335408), received between Dec 30, 2022 and Sep 24, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Sparking” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 21, 2025Class IIOpen, Classified

   Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

   Z-1563-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Thermal Decomposition of Device; Sparking

  Baxter received a report stating that a Connex Spot Monitor emitted sparks and burning smell. The power cable appeared to be blackened. The process step during which this occurred was unknown. There was no patient/user injury, medical intervention, symptom, or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878028 ↗
• MalfunctionSep 23, 2026Overheating of Device

  Baxter received a report stating that a Connex Spot Monitor that was charging in a wall socket located high on the wall first began making crackling noises and then started emitting smoke. They unplugged the device from the wall socket. A small hole had already burned into the device's power cord. All devices connected to the same socket were unplugged. The smoking stopped. The process step during which this occurred was unknown. The reporter did not know if there was any patient injury or death associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864166 ↗
• MalfunctionApr 2, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED BURN MARKS ON CABLE PIN. THERE WAS NO REPORTED INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750482 ↗
• InjuryAug 21, 2023Sparking; Flare or Flash; Unintended Electrical Shock; Sparking; Flare or Flash; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT SPARKS WERE OBSERVED WHEN THE NURSE PLUGGED THE CSM DEVICE INTO THE HALLWAY SOCKET TO BE CHARGED. THE SOCKET AND THE PLUG OF THE DEVICE TURNED COMPLETELY BLACK. IT WAS REPORTED THAT THE CAREGIVER RECEIVED AN ELECTRIC SHOCK IN THE SITUATION AND HIS RIGHT HAND TURNED BLACK, BUT THE ELECTRIC SHOCK DID NOT PENETRATE THE BODY. THE CUSTOMER ALSO STATED THAT IT IS UNKNOWN HOW SERIOUS THE INJURY WAS AND IF ANY MEDICAL AND/OR SURGICAL INTERVENTION WAS PERFORMED. MULTIPLE ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE PERFORMED, HOWEVER, AT THE MOMENT THE CUSTOMER HAS NOT PROVIDED ANY FURTHER DETAILS ON THE REPORTED INJURY. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: Electric Shock

  MAUDE report 17586244 ↗
• InjuryAug 17, 2023Sparking; Sparking

  THE CUSTOMER REPORTED THAT SPARKS WERE OBSERVED WHEN THE NURSE PLUGGED THE CSM DEVICE INTO THE HALLWAY SOCKET TO BE CHARGED. THE SOCKET AND THE PLUG OF THE DEVICE TURNED COMPLETELY BLACK. IT WAS REPORTED THAT THE CAREGIVER RECEIVED AN ELECTRIC SHOCK IN THE SITUATION AND HIS RIGHT HAND TURNED BLACK, BUT THE ELECTRIC SHOCK DID NOT PENETRATE THE BODY. THE CUSTOMER ALSO STATED THAT IT IS UNKNOWN HOW SERIOUS THE INJURY WAS AND IF ANY MEDICAL AND/OR SURGICAL INTERVENTION WAS PERFORMED. MULTIPLE ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE PERFORMED, HOWEVER, AT THE MOMENT THE CUSTOMER HAS NOT PROVIDED ANY FURTHER DETAILS ON THE REPORTED INJURY. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: Electric Shock

  MAUDE report 17562627 ↗
• MalfunctionDec 30, 2022Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  THE CUSTOMER REPORTED HAVING ISSUES WITH MULTIPLE POWER CORDS FROM THEIR VITAL SIGNS MONITORS. TO BE SPECIFIC IT WAS REPORTED; "EVENT 1: THE POWER CORD TO THE PATIENT MONITOR IS VERY HOT AND IT SMELLS BURNT. THE ENTIRE WALL OUTLET IS WARM. THE CABLE IS TAKEN OUT OF USE. ENGINEER CUTS UP THE PLUG AND CAN ASCERTAIN THAT THE NEUTRAL CONDUCTOR IS COMPLETELY CHARRED AND SITS LOOSE IN THE PLUG WITH ONLY A FEW STRANDS. EVENT 2: AN ADDITIONAL POWER CORD FOR THE SAME DEVICE MODEL IS REPORTED FOR FAILURE TO FUNCTION. WHEN ENGINEER CUTS THIS PLUG, IT CAN BE FOUND THAT THE NEUTRAL CONDUCTOR HAS COME OFF AND HAS NO CONTACT WITH THE PLUG PIN. TWO MORE CABLES FROM THE SAME DEPARTMENT HAVE BEEN X-RAYED. ONE OF THESE CABLES LOOKS ON THE X-RAY IMAGE TO BE ON THE WAY TO GET OFF INSIDE THE PLUG." THESE EVENTS HAVE BEEN CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076829 ↗