MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTERNAL PEDIATRIC PADDLE SET; INTERNAL DEBRILLATION PADDLES

Model Number M1743A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that "the handle is broken".No patient involvement was reported.

Manufacturer Narrative

(b)(4).The device was evaluated by a philips field service engineer and the symptom was clarified as the device failed to shock.

• Brand Name: INTERNAL PEDIATRIC PADDLE SET
• Type of Device: INTERNAL DEBRILLATION PADDLES
• 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: 4581538
• MDR Text Key: 5480335
• Report Number: 1218950-2015-01165
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030417
• 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: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1743A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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