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

Model Number 20

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device would only intermittently detect that a quik combo therapy cable was attached during testing.If the quik combo therapy cable is not detected, then a patient load (test or otherwise) may not be detected and defibrillation may not be possible, or delayed, if it were necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4): physio-control provided the customer, a biomedical engineer, with technical assistance.It was later confirmed by the biomedical engineer that the therapy connector assembly was replaced which resolved the reported issue.After observing proper device operation through functional and performance testing the unit was placed back into service for use.The device has not 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: 4241146
• MDR Text Key: 5066077
• Report Number: 3015876-2014-01338
• 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: 10/14/2014

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: 7 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/10/2014
• Date Device Manufactured: 01/08/2007
• 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