MAUDE Adverse Event Report: WIFI CSM,NIBP,MASIMO,BRAUN PRO6000,PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	75ME-B
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/09/2020
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 device came in with smoke damage and a melted connector.The power cord end was melted into the iec connector.The charger was opened and inside was full of soot.The black wire that goes to the device was pinched and flattened but no obvious cuts/abrasions.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: WIFI CSM,NIBP,MASIMO,BRAUN PRO6000,PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• MDR Report Key: 10651199
• Report Number: 1316463-2020-00006
• Device Sequence Number: 303999
• Product Code: MHX
• UDI-Device Identifier: 00732094209419
• UDI-Public: 732094209419
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/08/2020

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: 75ME-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: 09/09/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1