MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART FRX

Model Number 861304

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 aed did not pass self-diagnostic check.

Manufacturer Narrative

(b)(4).Product evaluation pending.Issue is being reported as alert could not be cleared by operator.

• Brand Name: HEARTSTART FRX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 843
• Manufacturer Contact: darren demerritt ; 23100 bothell everett hwy; bothell, WA 98021-8431 ; 4259082672
• MDR Report Key: 3952737
• MDR Text Key: 16775904
• Report Number: 3030677-2014-01263
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 050004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 861304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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