MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 ONSITE 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
Based on the available details, the evaluation determined that an investigation was required.The device was requested for investigation by philips ecr failure analysis.The customer was provided with a replacement device and we are expecting the return of the exchanged device.Upon receipt at philips the device will be evaluated, and the complaint will be reopened.Based on the information available there is insufficient information to confirm the reported problem.Based on the information available, no further action is necessary at this time.Insufficient information is available to support final failure analysis at this time.The customer was provided a replacement device to resolve the issue and we are expecting the return of the exchanged device.Upon receipt at philips the device will be evaluated, and the complaint will be reopened.The customer was provided a replacement device to resolve the issue and we are expecting the return of the exchanged device.Upon receipt at philips the device will be evaluated, and the complaint will be reopened.It has been concluded that no further action is required at this time.

• Brand Name: HS1 ONSITE 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: 18283827
• Report Number: 3030677-2023-04844
• Device Sequence Number: 6761508
• Product Code: MKJ
• UDI-Device Identifier: 00884838049130
• UDI-Public: 00884838049130
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: User Facility
• 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: 453564428191
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 03/28/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/16/2024; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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