MAUDE Adverse Event Report: WELCH ALLYN INC. CONNEX SPOT 35 WATT POWER SUPPLY; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	71WT-B
Medical Device Problem Codes	Fire (1245); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the back of the csm unit exploded; however, after further inspection it was determined that the device did not explode, but the battery burned.There was no reported injury.This event was captured under hillrom complaint ref # (b)(4).
Additional Manufacturer Narrative
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.The 7000-ps is the connex spot monitor 35 watt power supply.The device was received by hillrom for an initial inspection where it was determined that the battery assembly was burned.The power supply has been forwarded onto the supplier to conduct a thorough device analysis and hillrom will forward any findings in a supplemental report.Although the reported event did not result in a serious injury, the reported malfunction 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
The customer reported the back of the csm unit exploded; however, after further inspection it was determined that the device did not explode, but the battery burned.There was no reported injury.This event was captured under hillrom complaint ref # (b)(4).
Additional Manufacturer Narrative
Per the extent of the damage, only the cells were recovered and shipped by the customer.The cells came still joined together by the nickel tab that connects them in series to each other.The serial number of the pack could not be provided by the manufacturer after the initial request for additional information.The positive nickel tab on cell ¿b¿ touched the case above the notch location, producing a short circuit, which melted both, the positive nickel tab and the affected section of the case of the cell.As a result of the high current drawn, cell ¿b¿ heated up and ignited in fire, expelling it through the notch created and the safety vent.Cell ¿a¿ suffered as well from a thermal event as a result of the fire generated in cell ¿b¿, causing the extensive damage reported in the final product by the end customer.The likely root cause is an improper handling of the pack (possibly the pack was hit with a hard object, or it fell over a hard surface or object, or it was strongly pressed, etc.), which bent the nickel tab against the case of the cell, cutting through the isolation and leaving both metals in short circuit.Although there was no injury reported as a result of this event, if the reported event of fire were to recur, it could result in serious injury or death therefore, hillrom is reporting this event.

• Brand Name: CONNEX SPOT 35 WATT POWER SUPPLY
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 states street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16511754
• Report Number: 1316463-2023-00038
• Device Sequence Number: 6844133
• Product Code: MWI
• UDI-Device Identifier: 00732094210408
• UDI-Public: 732094210408
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/15/2023

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: 71WT-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: 02/10/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/15/2023
• 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