MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL

Model Number M4735A

Device Problems Sticking (1597); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer states the device's battery eject button is not working and battery is stuck in the unit.No pt involvement reported.No report of battery not functioning.

Manufacturer Narrative

(b)(4).A followup report will be submitted once the investigation is complete.

• 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: 3700443
• MDR Text Key: 15111436
• Report Number: 1218950-2014-00766
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• 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