MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL

Model Number M4735A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer contacted philips healthcare to report a malfunction of the bezel led on the device.There was no pt involvement.

Manufacturer Narrative

(b)(4).A follow up report will be submitted once the investigation is completed.

• Brand Name: HEARTSTART XL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810 ; 9786597429
• MDR Report Key: 3897022
• MDR Text Key: 18727327
• Report Number: 1218950-2014-02772
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1