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 Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that during a recent patient event, their device would not detect that the patient was connected via a quik-combo therapy cable.A backup device was available and used to provide care to the patient.There were no adverse effects to the patient as a result of the reported issue.No further details about the patient, or the event, were provided.

Manufacturer Narrative

The customer, a biomedical engineer, advised that he verified the reported issue.The biomedical engineer observed that pins had broken off of a quik-combo therapy cable and become lodged into the device's therapy connector assembly.Physio-control provided the customer with the part number and pricing for the parts necessary to complete the repair.It was later confirmed by the biomed that he replaced the device's therapy connector assembly and the quik-combo therapy cable to resolve the reported issue.After observing proper device operation through functional and performance testing the unit was placed back into service for use.Neither the device, nor the broken quik-combo therapy cable, have 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: 4301186
• MDR Text Key: 5267767
• Report Number: 3015876-2014-01463
• 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: 11/10/2014

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: 3202488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/05/2014
• Date Device Manufactured: 11/06/2003
• 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