MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 20

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's therapy connector assembly and completed other, unrelated, repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio further examined the removed therapy connector assembly and confirmed that a broken pin was stuck in the connector.As a result, another quik-combo therapy cable could not be connected to the device.It was later confirmed by the customer, a biomedical engineer, that the damaged quik-combo therapy cable was disposed of on-site and therefore not available for further examination by physio-control.

Event Description

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

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 9706
• Manufacturer Contact: yuchol kim ; 4258674000
• MDR Report Key: 5648571
• MDR Text Key: 45041980
• Report Number: 3015876-2016-00549
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• 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: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2004
• 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