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

Model Number M5068A

Device Problem Failure of Device to Self-Test (2937)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It has been reported that the device is failing self-test.

Manufacturer Narrative

Correction to become aware date only to update from 11/20/2020 to 11/19/2020.

• Brand Name: HEARTSTART HOME
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer Contact: shannon decker ; 22100 bothell everett hwy; bothell, WA 98021
• MDR Report Key: 10891596
• MDR Text Key: 217996395
• Report Number: 3030677-2020-01911
• Device Sequence Number: 1
• Product Code: NSA
• UDI-Device Identifier: 00884838075849
• UDI-Public: (01)00884838075849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 020715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5068A
• Device Catalogue Number: 861282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1