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

Model Number M5068A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

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

• 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; bldg a; bothell, WA 98021
• MDR Report Key: 8349778
• MDR Text Key: 136603451
• Report Number: 3030677-2019-00348
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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
• Device Operator: Health Professional
• Device Model Number: M5068A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0642-2013, Z-0643-2013
• Patient Sequence Number: 1