MAUDE Adverse Event Report: WELCH ALLYN VSM6800/SPM/ST/RADIO/PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	68MXTX-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned for inspection.Investigation into the reported incident is on going.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported a cvsm caught fire in the physical therapy room.There was no adverse event reported.This incident was captured under complaint ref # (b)(4).
Additional Manufacturer Narrative
Images of the damaged unit were inspected by the manufacturers, from looking at the remains of the cvsm 68mxtx-b it is evident that the 9-cell lithium-ion battery pack had cells fail which caused a fire.It was determined that the battery involved in the event showed a different design to the original battery that is recommended for use with the cvsm device.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.Although there was no adverse event associated with this event and the reported malfunction was found to have been caused due to use of a non recommended battery pack.If the reported event were to recur it could lead to serious injury or death.
Event or Problem Description
The customer reported a cvsm caught fire in the physical therapy room.There was no adverse event reported.This incident was captured under complaint ref # (b)(4).

• Brand Name: VSM6800/SPM/ST/RADIO/PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21216522
• Report Number: 1316463-2025-00012
• Device Sequence Number: 8639676
• Product Code: MHX
• UDI-Device Identifier: 00732094150933
• UDI-Public: 732094150933
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/24/2025

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: 68MXTX-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: 01/06/2025
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown