MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 (W B) ONSITE DEFIB, US ENGLISH,EXCHG; AED

Model Number	M5066A
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	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the aed is not working properly and stated that the pads are not usable when blue i button is pressed.

• Brand Name: HS1 (W B) ONSITE DEFIB, US ENGLISH,EXCHG
• 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: heidi fraley ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16135778
• Report Number: 3030677-2023-00159
• Device Sequence Number: 15114620
• Product Code: MKJ
• UDI-Device Identifier: 00884838023741
• UDI-Public: 00884838023741
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Other
• 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: Other
• Device Model Number: M5066A
• Device Catalogue Number: 453564592771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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