MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 HOME DEFIB, US ENGLISH, 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 to philips that the device is failing self-test.
Additional Manufacturer Narrative
The pads (lot c101322-04) were returned to philips for additional analysis.The complaint was escalated for technical complaint investigation and the results indicate that the alleged failure was the pads cartridge magnet was missing.Device design supports alerting users/health care professionals through the self-test feature to ensure the device is adequately maintained to supply therapy as intended.This design feature mitigates risk to the patient in a critical care event.Based on the information available and the testing conducted, the cause of the reported problem was that the pads cartridge magnet was missing., which created the error msg ¿replace pads cover¿.The reported problem was confirmed.The customer was provided with replacement pads to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
Corrected the health impact grid from no health consequences or impact to no patient involvement.

• Brand Name: HS1 HOME DEFIB, US ENGLISH, 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17886664
• Report Number: 3030677-2023-03965
• Device Sequence Number: 6995020
• Product Code: MKJ
• UDI-Device Identifier: 00884838049130
• UDI-Public: 00884838049130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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: 453564428311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 01/11/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/07/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2015
• 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