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

Model Number	73MT-B
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported device has visible charring and produced sparks when plugged in.There was no injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
No further information is available on the device at this time.The device is being returned to the hillrom manufacturer for a thorough investigation.Hillrom will submit a final report with investigation conclusion on this incident.
Event or Problem Description
Customer reported device has visible charring and produced sparks when plugged in.There was no injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The connex spot monitors 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 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.The 7000-ps is the connex spot monitor 35 watt power supply hillrom requested for the faulty device to be returned for investigation into the root cause of the reported malfunction however, the device has not been received back from the customer.Although there was no serious injury as a result of this event, if the reported malfunction of sparking and charring of the power supply were to recur, it could result in a serious injury or death, therefore, hillrom is reporting this malfunction.

• Brand Name: BT 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; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17787987
• Report Number: 1316463-2023-00208
• Device Sequence Number: 6253291
• Product Code: MWI
• UDI-Device Identifier: 00732094210071
• UDI-Public: 732094210071
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 73MT-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: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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