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

Model Number 20

Device Problems Failure to Charge (1085); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2014

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer's device and observed that it would not power on due to damage and incorrect reassembly caused by the biomedical engineer during his attempt to replace the therapy connector assembly.Physio-control then made the necessary repairs to the device.Once the unit was repaired and able to power on again, physio was able to confirm that the new therapy connector assembly installed by the biomedical engineer had resolved the original reported issue.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that during a recent patient event their device would not charge and defibrillate the patient.Medical personnel were attempting to cardiovert the patient when the issue occurred.A backup device was available and used to successfully cardiovert the patient.It took approximately two (2) minutes to obtain and use the backup device.No further details about the patient or the event were provided.No adverse effects to the patient were reported as a result of the reported issue.

Manufacturer Narrative

(b)(4): the customer, a biomedical engineer, examined the device but was unable to duplicate the reported issue of the device failing to charge and provide defibrillation energy.During the biomed's testing, however, he did observed that when he put moved the quik-combo therapy cable near the therapy connector assembly that paddles lead ecg would not longer show the simulated rhythm (flat-line).The biomedical engineer then replaced the therapy connector assembly but was unable to further test the device to confirm that it had resolved the issue.The device has since been returned to physio-control for further evaluation.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.

• 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: 3841350
• MDR Text Key: 11964812
• Report Number: 3015876-2014-00601
• 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,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2004
• 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