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 06/04/2014

Event Type  malfunction  

Manufacturer Narrative

The initial medwatch report indicates: device manufacture date - 03/03/2002.The initial medwatch report should indicate: device manufacture date - 03/03/2003.

Manufacturer Narrative

Physio-control evaluated the device and verified the reported failure.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.

Event Description

The customer initially reported that their device was showing its service indicator.Upon further evaluation of the device by physio-control, it was observed that the device would not complete its boot up cycle.There was no patient use associated with the reported failure.

Manufacturer Narrative

Physio-control further evaluated the removed flex cable assembly and observed that several contacts are open on plug connector p21.The contacts b1, c1, c2, swvbus, grnd, and usb1+ were all found to be open at the pin flex solder connection.

Manufacturer Narrative

Physio-control replaced the flex cable assembly which connects the user interface pcb to the pcb stack.Physio also performed unrelated repairs and then observed proper device operation through functional and performance testing.The device was returned to the customer for use.

• 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: 3927869
• MDR Text Key: 12279948
• Report Number: 3015876-2014-00794
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• 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: 06/16/2014
• Is the Reporter a Health Professional?: No
• Device Age: 11 YR
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2003
• 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