MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DEFIBRILLATOR

Model Number 43120A

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the defibrillator turns off.There was no report of patient involvement.

Manufacturer Narrative

(b)(4).

• Brand Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd; andover, MA 01810 ; 9786597804
• MDR Report Key: 4333467
• MDR Text Key: 21496982
• Report Number: 1218950-2014-05799
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K844740
• 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: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43120A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/1988
• 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