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	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/06/2023
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 mode.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 mode.The device was returned to hillrom for repair.Upon inspection it was determined that the issue was with the power cord and there was no charring or signs of overheating observed internally with the device, the device was factory calibrated and the customer was sent a replacement power cord.The damaged power cord was forwarded on to the manufacturer for further investigation into the root cause of the malfunction.The customer did not provide the necessary information to determine the severity of the injury.Based on the limited details provided, there is no indication that the reported burn was a serious injury.Device inspection is pending.However, if the report of a spark were to recur, it would be likely to cause or contribute to a death or serious occur.If additional relevant information is received, the complaint will be reassessed, and the injury will be categorized accordingly.Any additional information received regarding this event will be submitted in a supplemental report.
Event or Problem Description
The customer reported the vital signs monitor power cord sparked and burned.The user pulled the power cord out of the wall and burned their hands.No medical intervention was reported at the time of the initial report.Multiple follow up attempts were performed, but no additional information was obtained from the customer.This incident was captured under hillrom ref # (b)(4).
Event or Problem Description
The customer reported the vital signs monitor power cord sparked and burned.The user pulled the power cord out of the wall and burned their hands.No medical intervention was reported at the time of the initial report.Multiple follow up attempts were performed, but no additional information was obtained from the customer.This incident was captured under hillrom ref # (b)(4).
Additional Manufacturer Narrative
A sustainability investigation was completed on the returned power cord and no issues were found.The plug was disassembled, and no abnormality was observed in the welding between the terminal and wire.The returned sample passed hi-pot testing.Based on the inspection of the plug showing traces of fire on the live wire terminals, it is likely the socket was abnormal, or the plug was not properly inserted into the socket.Based on this information, no further actions are required.

• 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 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17304386
• Report Number: 1316463-2023-00157
• Device Sequence Number: 6506183
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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