MAUDE Adverse Event Report: WELCH ALLYN INC VSM6500/SPN/ST/RADIO/PLUGB; MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	65NTXX-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (nibp) pulse rate (pr) nr , noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2) , body temperature in normal and axillary modes.The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.Monitoring can be accomplished on the vsm 6000 series bedside monitor itself, and the vsm 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.G., at a central station).Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.Device inspection by baxter is still pending, a supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported that the cvsm device caught fire.It was additionally stated that staff was able to unplug the device from ac power and put the fire with a fire extinguisher.There was no adverse event reported.
Additional Manufacturer Narrative
The device was returned for inspection where the customers allegation was confirmed.The li-ion battery pack was found to have caused the fire.The battery contacts were measured and the shape of the contacts were examined to determine if the battery pack was from an approver supplier.It was determined that the battery pack in the cvsm was not a baxter approved battery pack.The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (nibp).Pulse rate (pr) nr.Noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2).Body temperature in normal and axillary modes.The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.Monitoring can be accomplished on the vsm 6000 series bedside monitor itself, and the vsm 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.G., at a central station).Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.The user manual contains the following statement: warning defective batteries can damage the monitor.If the battery shows any signs of damage or cracking, it must be replaced immediately and only with a battery approved by welch allyn.Although there was no adverse event and the issue was due to incorrect use of a non approved battery with the device, if the reported incident were to recur, it could lead to serious injury or death.
Event or Problem Description
Customer reported that the cvsm device caught fire.It was additionally stated that staff was able to unplug the device from ac power and put the fire with a fire extinguisher.There was no adverse event reported.

• Brand Name: VSM6500/SPN/ST/RADIO/PLUGB
• Common Device Name: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 23462513
• Report Number: 1316463-2025-00089
• Device Sequence Number: 8983751
• Product Code: MWI
• UDI-Device Identifier: 00732094088151
• UDI-Public: 732094088151
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 65NTXX-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown