MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 DEFIBRILLATOR, DUTCH, EXCHANGE; AED

Model Number	M5068A
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the device is failing self-test.

• Brand Name: HS1 DEFIBRILLATOR, DUTCH, EXCHANGE
• Common Device Name: AED
• 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: marie-therese assaf ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15174599
• Report Number: 3030677-2022-03840
• Device Sequence Number: 20419976
• Product Code: MKJ
• UDI-Device Identifier: 00884838049130
• UDI-Public: 00884838049130
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P160029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: Other
• Device Model Number: M5068A
• Device Catalogue Number: 453564428301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 03/03/2023
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/09/2022; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown