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

Model Number 20

Device Problem Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that when using their device with the hard paddles assembly, paddles lead ecg was not possible.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4): physio-control examined the customer's device and verified the reported issue.Physio determined that the cause of the reported issue was the hard paddles assembly.Physio then replaced the assembly with a new set of hard paddles from the customer's existing inventory.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.The removed hard paddles assembly was scrapped by the customer.

• 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: 4371391
• MDR Text Key: 5263719
• Report Number: 3015876-2014-01578
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/09/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2003
• 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