MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS BATTERY 14.8V, 6.3 A LI-ON BATTERY

Model Number M3538A

Device Problems Failure to Charge (1085); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported to philips healthcare that the battery for a heartstart mrx was unable to charge.There was no patient involvement.

Manufacturer Narrative

Pr#: (b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: BATTERY 14.8V, 6.3 A LI-ON BATTERY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman rd.; andover, MA 01810 ; 9786597844
• MDR Report Key: 3977221
• MDR Text Key: 4633520
• Report Number: 1218950-2014-02659
• Device Sequence Number: 1
• Product Code: MJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3538A
• Device Lot Number: 12250-0048-P
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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