MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Catalog Number VLP12-02B

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2014

Event Type  malfunction  

Manufacturer Narrative

Physio-control further examined the removed therapy connector assembly and verified the reported issue.Physio observed that the low voltage pin from a quik-combo therapy cable had broken off and become lodged into the therapy connector assembly.

Event Description

The customer contacted physio-control to report that a pin from a quik-combo therapy cable assembly had broken off and become lodged into their device's therapy connector.As a result, defibrillation was not possible because another cable would not be able to plug into the device.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control examined the customer's device and verified the reported issue.Physio then replaced the therapy connector assembly to resolve the reported issue and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.The quik-combo therapy cable with missing pin was disposed of by the customer prior to physio's arrival to evaluate the device.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• 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: 4413830
• MDR Text Key: 12890164
• Report Number: 3015876-2015-00038
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VLP12-02B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2014
• Is the Reporter a Health Professional?: No
• Device Age: 14 YR
• Event Location: Hospital
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2001
• 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