MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number	M3535A
Medical Device Problem Codes	Battery Problem (2885); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that the rfu indicator displayed a red x and the alarm sounded.There was no reported patient involvement,.
Additional Manufacturer Narrative
The battery was returned to the failure analysis lab for evaluation.The battery received partially charged at a minimum of 80% capacity, was able to charge (in both mrx heartstart unit and cadex c7400 battery analyzer), calibrate, and seemed to operate normally.The battery fitted in compartment and was intact with the wing well snapped into place.There is no fault found with this battery.
Event or Problem Description
It was reported to philips that the rfu indicator displayed a red x and the alarm sounded.There was no reported patient involvement.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12138031
• Report Number: 3030677-2021-12795
• Device Sequence Number: 19846584
• Product Code: MKJ
• UDI-Device Identifier: 00884838002791
• UDI-Public: 00884838002791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Distributor Facility Aware Date: 06/16/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1