MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX AIRWORTHY; DEFIBRILLATOR

Model Number	M3536M
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is failing the auto test.There was reportedly no patient involvement.The customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).The heartstart mrx device and all associated service/support was discontinued on (b)(6) 2022.As troubleshooting was not completed for the device, the reported issue could not be verified and a cause could not be established.The customer was aware of the end of life terms and the device remains at the customer site.No further investigation or action is warranted.

• Brand Name: HEARTSTART MRX AIRWORTHY
• 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: olympia betonio ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 13953246
• Report Number: 3030677-2022-01794
• Device Sequence Number: 14644494
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: 00884838006676
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: M3536M
• Device Catalogue Number: M3536M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/30/2022
• 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