MAUDE Adverse Event Report: WELCH ALLYN, INC. SPOT 4400 W NIBP SURETEMP NONIN PLUG B; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	44WT-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 welch allyn spot vital signs non-invasively and automatically measures systolic and diastolic blood pressure, pulse rate, and oxygen saturation (spo2) for adult and pediatric patients.Further, the welch allyn spot vital signs measures temperature invasively in natural body orifices (i.E., mouth and rectum).The spot vs device was returned to welch allyn for investigation.The returned ac power cord had significant damage to the male end.The line and neutral pin of the power cord was charred and the surrounding over molding was melted.Both the line and neutral pins from the power supply were removed and melted into the ac power cord.The ground pin received less damage compared to line and neutral pins.The evaluation and investigation indicated that a short occurred at the ac input of the power supply.Further testing of the spot vs device and power supply indicated that ingress of liquid in the ac power receptacle caused a short and a fire which melted the case of the power supply and burnt the board.Welch allyn will continue to monitor complaint trends for this type of alleged malfunction.Based on this information, no further action is required.
Event or Problem Description
Welch allyn received a report from the account stating the spot vs device power supply caught fire.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: SPOT 4400 W NIBP SURETEMP NONIN PLUG B
• 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: 11064611
• Report Number: 1316463-2020-00014
• Device Sequence Number: 1047561
• Product Code: MWI
• UDI-Device Identifier: 00732094309409
• UDI-Public: 732094309409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/23/2020

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: 44WT-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: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1