MAUDE Adverse Event Report: WELCH ALLYN, INC. VSM6800/SPM/ST/RADIO/PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	68MXTX-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), total hemoglobin concentration (sphb), and 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.The cvsm device was returned to welch allyn for investigation.The evaluation and investigation indicated that the root cause was an internal failure with the power supply inside the cvsm that caused the fire.Welch allyn has notified the power supply manufacturer of the event for a root cause failure analysis.This is the first occurrence of this failure.Welch allyn will continue to monitor complaint trends for this type of alleged malfunction.If any additional relevant information is identified following completion of the root cause analysis by the manufacturer, the additional relevant information will be submitted in a supplemental report.Based on this information, no further action is required.
Event or Problem Description
Welch allyn received a report from the account stating the cvsm device caught fire after plugging in the device at set up.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).

• Brand Name: VSM6800/SPM/ST/RADIO/PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street rd.; skaneateles falls NY 13153
• MDR Report Key: 11018816
• Report Number: 1316463-2020-00012
• Device Sequence Number: 4396534
• Product Code: MWI
• UDI-Device Identifier: 00732094150933
• UDI-Public: 732094150933
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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
• Operator of Device: No Information
• Device Model Number: 68MXTX-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: 11/24/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1