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

Model Number	74MT-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hillrom has received the device in the service centre and results of preliminary investigation have shown that the ac power adapter burned/charred.The device will be forwarded to the hillrom manufacturer for a thorough investigation.Hillrom will submit a final report with investigation conclusion as soon as the findings will be available.
Event or Problem Description
Customer reported the power supply of device caught fire and burnt.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Preliminary investigation showed that the ac power adapter was burned/charred.Customer returned the power adapter but failed to provide the power cord which is the part of the device that the malfunction was alleged to have occurred.As the customer disposed of the power cord we are unable to complete the investigation and a root cause cannot be established.The connex spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), respiration rate, and body temperature in normal and axillary modes of neonatal, pediatric 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.This product is available for sale only upon the order of a physician or licensed health care professional.A root cause cannot be determined as the power cord was not returned but it is suspected that the customer was using a power cord that was not approved by hillrom which may have contributed to the burning of the adapter.Customer contacted and advised to stop using power cord.Based on this information no further action is required.
Event or Problem Description
Customer reported the power supply of device caught fire and burnt.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint#: (b)(4).

• Brand Name: WFR,CSM,NIBP,MASIMO,SURETEMP,PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13059015
• Report Number: 1316463-2021-00088
• Device Sequence Number: 3902934
• Product Code: MWI
• UDI-Device Identifier: 00732094209679
• UDI-Public: 732094209679
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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: 74MT-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: 11/25/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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