MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ONSITE; AED

Model Number	M5066A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that the device is failing self-test.

• Brand Name: HEARTSTART ONSITE
• Common Device Name: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 10152752
• Report Number: 3030677-2020-00955
• Device Sequence Number: 11603172
• Product Code: MKJ
• UDI-Device Identifier: 00884838049130
• UDI-Public: (01)00884838049130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 020715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1