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

Model Number 20

Device Problem Failure to Charge (1085)

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

Event Date 04/11/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that the device user(s) stated that the unit would not charge when prompted during a recent patient event.As a result, the device could not be used to provide defibrillation therapy.The device user(s) had advised the biomedical engineer that they had pressed the charge button on the device multiple times but that the unit would not charge.The device user(s) then obtained a backup device and used it to successfully treat the patient.There were no reported 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

(b)(4) the biomedical engineer advised that after thoroughly testing the device he was unable to duplicate, or verify, the reported issue.There were no event codes in the device's memory, nor were there any electronic patient records in the memory that corresponded to date and time of the patient event.The biomedical engineer advised that it was his opinion that the device may not have been properly attached to the patient during the event, but he could not be certain with the information he had been provided by the device user(s).After observing proper device operation through functional and performance testing the unit was placed back into service for use.Physio-control has made numerous attempts to contact the customer for additional information about the event; however, no response appears to be forthcoming.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

• 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: 3801067
• MDR Text Key: 4475323
• Report Number: 3015876-2014-00517
• 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: 04/11/2014

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: 8 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/08/2014
• Date Device Manufactured: 11/22/2005
• 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