MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SMALL SWITCHED INT PDLS; PHILIPS HEARTSTART INT PDLS

Model Number M4744A

Device Problem Device Inoperable (1663)

Patient Problem Death (1802)

Event Date 10/05/2015

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

The customer reported that the internal paddles failed during use on a patient.Note that the customer reported two internal paddle sets failed during this event, the second paddle set failure is addressed in mdr 1218950-2015-05488.The involved patient died and the clinicians stated that the patient death was caused by non functioning internal paddles.

Manufacturer Narrative

One set of internal paddles was returned to philips for evaluation.A philips quality engineer evaluated the returned internal paddle set.The reported symptom could not be reproduced.The device passed all performance verification testing.The internal paddles were able to deliver a shock into a test load 20 times without a failure.It was noted that the returned internal paddles were almost five years old; the pins on the green connector showed wear and contamination, the gold plating on the pins was worn off and nickel layer was exposed, and the connector gasket was missing.There were no electronic event files or ecg monitoring waveforms of the incident available for review.The sterilizable defibrillator paddles application note has instructions on how to perform mechanical, visual, functional, and continuity checks.It notes that ¿paddle life depends upon the frequency and method of sterilization and handling, rather than age.All buttons, cables and electrodes must be routinely tested, as described in ¿paddle checks¿ on page 2.Replace paddles when they fail testing or when functionality or appearance is questionable.¿ philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause cannot be determined.

• Brand Name: SMALL SWITCHED INT PDLS
• Type of Device: PHILIPS HEARTSTART INT PDLS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5144121
• MDR Text Key: 28026139
• Report Number: 1218950-2015-05489
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M4744A
• Device Lot Number: 5-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 7 MO
• Patient Weight: 6