MAUDE Adverse Event Report: WELCH ALLYN INC. SPOT LXI BPWST+ ENG 110V; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	450T0-E1
Medical Device Problem Codes	Electrical Shorting (2926); Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported power supply had a short.The power cord flashed and now no longer works.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
No further information is available on the devices at this time.Hillrom has requested for the power cord to be returned in order to conduct a thorough analysis.Hillrom will submit a final report with the investigation conclusion on this event.
Additional Manufacturer Narrative
The spot vital signs lxi measures systolic and diastolic pressure (excluding neonates), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (spo2) as well as calculates mean arterial pressure (map).Furthermore, spot vital signs lxi allows the entry of height, weight, respiration rate, and pain level.Spot vital signs lxi also calculates body mass index (bmi) following height and weight entry.For protection against shock, electrically powered welch allyn medical devices are designed, validated and manufactured per the isolation standards in "iec 60601-1".The standard is referenced in the instructions for use.This assures that the mains power is isolated to prevent injury to the patient and user from the mains electrical power.As the device was not returned by the customer, a thorough investigation into the reported malfunction could not be performed.Although the reported event did not result in a serious injury, the report of power supply having a short and power cord flashing could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.
Event or Problem Description
Customer reported power supply had a short.The power cord flashed and now no longer works.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: SPOT LXI BPWST+ ENG 110V
• 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: 16875831
• Report Number: 1316463-2023-00103
• Device Sequence Number: 5822458
• Product Code: MWI
• UDI-Device Identifier: 00732094003673
• UDI-Public: 732094003673
• Combination Product (Y/N): N
• 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): 06/27/2023

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: 450T0-E1
• Was Device Available for Evaluation?: No
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/27/2023
• 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