MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SWITCHED INTERNAL PADDLES - 7.5 CM

Model Number M4741A

Device Problem Failure to Discharge (1169)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the device cannot discharge a shock.There was no reported patient involvement.

• Brand Name: SWITCHED INTERNAL PADDLES - 7.5 CM
• Type of Device: INTERNAL PADDLES
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5857297
• MDR Text Key: 51504508
• Report Number: 1218950-2016-04840
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021453
• 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: 07/22/2016

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: M4741A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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