MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 ONSITE DEFIB, US ENGLISH, EXCHANGE; AED

Model Number	M5066A
Medical Device Problem Code	Failure to Power Up (1476)
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 will not power on.
Additional Manufacturer Narrative
Available details indicate the support center staff provided remote troubleshooting assistance.The customer was instructed to insert the battery, but the device still did not power on.The customer advised they had checked the device the prior week and it did not power on then.The customer also mentioned they used the device over four months ago and they just changed out the pads set.They did not know if the device was beeping previously or for how long.The support center advised they would replace the battery and follow up to ensure this powers on the device.The replacement battery was sent, tracked, and delivered to the customer site.The support center followed up with the customer who advised the new battery was received and the aed powered on with no issues.The device is not available for additional investigation as it was returned to service.Based on the information available and the testing conducted, the cause of the reported problem was a battery failure.The reported problem was confirmed.A replacement battery was provided, resolving the complaint issue and returning the device to full functionality.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The customer was provided a replacement battery 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.

• 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: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15874256
• Report Number: 3030677-2022-05369
• Device Sequence Number: 11379802
• Product Code: MKJ
• UDI-Device Identifier: 00884838049130
• UDI-Public: 00884838049130
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: 453564428191
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown