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

Model Number	68NXTX-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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), 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 the reported event did not result in a serious injury, the reported incident could contribute to a serious injury if it were to recur, therefore, baxter considers this event reportable.Should additional information be provided, a supplemental report will be filed.However, based on the information provided at this time no further action is required.
Event or Problem Description
Customer reported cvsm device caught fire.This incident was captured under hillrom ref #(b)(4).

• Brand Name: VSM6800/SPN/ST/RADIO/PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21077916
• Report Number: 1316463-2025-00001
• Device Sequence Number: 15145044
• Product Code: MHX
• UDI-Device Identifier: 00732094150810
• UDI-Public: 732094150810
• 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
• Report Date (Section B): 01/06/2025

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: 68NXTX-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/06/2025
• 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