MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART SLA BATTERY; DEFIBRILLATOR

Model Number	M3516A
Medical Device Problem Codes	Battery Problem (2885); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporter phone #/reporting institution phone #: n/i.
Event or Problem Description
It was reported to philips that the customer's new aed (automated external defibrillator) battery is faulty.There was no reported patient impact or injury.
Additional Manufacturer Narrative
This report is based on information provided by philips local customer support and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl defibrillator indicating that the aed (automated external defibrillator) unit was beeping.Available details indicated that, the aed unit was beeping, prompting the customer to order a new battery.However, the issue persisted, and the customer reported that the new battery was faulty.This problem was due to the use of a counterfeit battery supplied by an unapproved third-party distributor or a battery that was over 3.5 years old, as philips has not produced or supplied the m3516a battery model since december 31, 2020.Additionally, defective pads could cause the device to beep and lead to premature battery drain.Therefore, the aed department sent replacement pads as a precautionary measure to address potential issues with the device.The device remains at the customer site, and no further evaluation is warranted at this time.Based on the information available and the testing conducted, we were unable to determine the cause of the reported problem.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The aed department resolved the issue by delivering new pads to the customer.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened for reassessment.

• Brand Name: HEARTSTART SLA BATTERY
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 19359956
• Report Number: 3030677-2024-01756
• Device Sequence Number: 6342925
• Product Code: MKJ
• UDI-Device Identifier: 00884838002760
• UDI-Public: 00884838002760
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: M3516A
• Device Catalogue Number: M3516A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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