MAUDE Adverse Event Report: WELCH ALLYN, INC. VALUE CSM,NIBP,SPO2,SURETEMP,PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	71WT-B
Medical Device Problem Codes	Fire (1245); Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The connex spot monitors (csm) are intended to be used by clinicians and medically qualified personnel for monitoring of non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arteriolar haemoglobin (spo2), and body temperature in normal and axillary modes of neonatal, paediatric and adult patients.The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.The csm device was returned to welch allyn for investigation.The evaluation and investigation indicated that the root cause was an internal failure of the lithium ion battery made by (b)(4).This failure caused a thermal runaway of the lithium ion battery that eventually resulted in a fire.Further root cause analysis of the battery pack will be completed by the battery manufacturer, (b)(4).Further testing of the csm device indicated that the csm was functioning as intended during the events that lead to the eventual failure.Log files from the device indicated the device provided three "battery critically low" notifications to the user prior to the battery failure.The device then performed a controlled shutdown due to the low battery voltage level, indicating the device was operating as designed.Automated test equipment (ate) testing was performed on the csm device and the csm printed circuit board assembly (pcba) and both passed accordingly.Welch allyn has notified the battery manufacturer of the event and has issued a corrective action request to the supplier.This is the first occurrence of this failure.Welch allyn will continue to monitor complaint trends for this type of alleged malfunction.
Event or Problem Description
Welch allyn received a report from the account stating the csm device caught fire while the device was charging and not in use.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: VALUE CSM,NIBP,SPO2,SURETEMP,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 0220
• MDR Report Key: 9532431
• Report Number: 1316463-2019-00001
• Device Sequence Number: 2534976
• Product Code: MWI
• UDI-Device Identifier: 00732094210408
• UDI-Public: 732094210408
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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: 71WT-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1