MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problem Power Problem (3010)

Patient Problem Death (1802)

Event Date 03/05/2014

Event Type  Death  

Event Description

The customer contacted physio-control to report that during a recent patient event their device powered off multiple times while attempting to defibrillate.The patient, a (b)(6) old male, had just come out of cardiac bypass surgery and was in the process of being moved to icu when he went into cardiac arrest.The customer powered the device on using dc (battery) power only and made two attempts to defibrillate the patient.Both times that the customer attempted to defibrillate, when they pressed the shock button and the device powered off by itself.The customer then obtained a backup device (also a lifepak 20) and plugged in the same qc therapy cable and qc defibrillation electrodes and were able to provide a 300 joule defibrillation shock to the patient.Multiple additional shocks were provided using the backup device.There was approximately 8 minutes between their first attempt to defibrillate the patient and when they provided the successful shock.The customer also advised that cpr was performed on the patient throughout the event and that acls protocol medications were delivered.The patient did not survive the event.

Manufacturer Narrative

(b)(4).The biomedical engineer at the customer's facility examined the device and found no issues with the device's ability to power on and defibrillate.The device has been returned to physio-control's for evaluation.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Manufacturer Narrative

Physio-control examined the customer's device but was unable to duplicate the reported issue.Physio then completed unrelated repairs and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 3727799
• MDR Text Key: 4325431
• Report Number: 3015876-2014-00365
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 3202487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 04/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2003
• 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: 62 YR
• Patient Weight: 104