MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ONSITE

Model Number M5066A

Device Problem Device Operates Differently Than Expected (2913)

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 ONSITE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 843
• Manufacturer Contact: darren demerritt ; 22100 bothell everett hwy; bothell, WA 98021-8431 ; 4259082672
• MDR Report Key: 4184420
• MDR Text Key: 20976116
• Report Number: 3030677-2014-02328
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020715
• 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: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5066A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1