MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL

Model Number M4735A

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the battery fails the 3 hr holding test.There was no pt involvement.

Manufacturer Narrative

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

• Brand Name: HEART START XL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810 109
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810-1099 ; 9786597429
• MDR Report Key: 3970166
• MDR Text Key: 4750010
• Report Number: 1218950-2014-02403
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• 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: 04/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2010
• 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