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

Model Number	M5068A
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 does not power on.
Additional Manufacturer Narrative
Available details indicate that the device does not power up and turn on.Details provided in an update from the source case indicate that the customer was given a replacement battery under warranty and per email response replacing the aed fixed the issue.Aed replacement order (b)(4).The part was not returned for additional investigation.Based on the information available, a warranty replacement of battery was given to customer and aed replacement order (b)(4).Based on the information available and results of additional analysis, no further action is necessary at this time.No capa will be initiated based on this record; a corrective action request will be initiated if a trend is discovered through periodic monitoring.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 battery the was found dead was still currently under warranty and could be replaced.The customer was given under warranty a replacement battery and per email response replacing the aed fixed the issue.Aed replacement order (b)(4).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 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: marie-therese assaf ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15629218
• Report Number: 3030677-2022-04697
• Device Sequence Number: 8035308
• Product Code: MKJ
• UDI-Device Identifier: 00884838049130
• UDI-Public: 00884838049130
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: M5068A
• Device Catalogue Number: 453564428311
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2015
• 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