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

Model Number 861304

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Death (1802)

Event Date 01/26/2021

Event Type  Death  

Event Description

The user is questioning why the device did not shock during a patient use event.The patient did not survive.

• Brand Name: HEARTSTART FRX
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett hwy; bothell, WA 98021
• MDR Report Key: 11254191
• MDR Text Key: 229529854
• Report Number: 3030677-2021-00186
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: 050004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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
• Patient Outcome(s): Death