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

Model Number 20

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that when upon powering a device on for testing the unit displayed a "cannot charge" message on the display.When the biomedical engineer pressed the charge button on the main keypad assembly, the device displayed a "connect cable" message, indicating that the hard-paddles were not being detected.There was no patient use during the reported event; the customer was testing the device.

Manufacturer Narrative

(b)(4).Physio-control contacted the biomedical engineer for additional information.The biomedical engineer stated that he has replaced the hard-paddles assembly which resolved the reported failure and after observing proper device operation through functional and performance testing the unit was placed back into service for use.Neither the device, nor the original hard-paddles assembly have been returned to physio-control for evaluation.

• 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: 3764941
• MDR Text Key: 4550111
• Report Number: 3015876-2014-00450
• 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
• Report Date: 03/24/2014

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: 20
• Device Catalogue Number: 3202487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/22/2014
• Date Device Manufactured: 04/23/2004
• 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