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

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

The customer reported that their device powers up to a completely white screen.This white screen is indicative of a device lockup which would not allow the device to deliver defibrillation energy, if needed.There was no report of any patient use associated with the reported lockup.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and was unable to verify the reported failure.Physio performed unrelated repairs, then observed proper device operation through functional and performance testing and the device was returned to the customer for use.The cause of the reported failure 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: 4245406
• MDR Text Key: 16304095
• Report Number: 3015876-2014-01349
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/23/2014
• Is the Reporter a Health Professional?: No
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2006
• 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