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

Model Number 20

Device Problem Device Inoperable (1663)

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

Event Date 06/28/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that during a recent patient event the display on their device turned white.A white display is indicative of a potential device lock-up.The customer obtained a backup device that was readily available and used it to provide care to the patient.There were no reported adverse effects to the patient as a result of the reported issue.No further information about the patient or the event were provided.

Manufacturer Narrative

(b)(4).Physio-control examined the customer's device but was unable to duplicate the reported issue.Physio did observe that the user interface (ui) to stack flex cable assembly had a small tear near the cable-mounted plug connector, designator p21.As a precaution, the ui to stack flex cable assembly was then replaced and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.

Manufacturer Narrative

After receiving their device back from physio-control, the customer immediately contacted physio to report that their device was booting up with a white display which is indicative of a device lock up condition.There was no patient use associated with the reported issue; the customer, a biomedical engineer, was inspecting the device after receiving it back from physio.The device was returned to physio for evaluation.Physio examined the customer's device but was unable to duplicate or verify the reported issue.As a precaution, physio replaced both the system controller (sc) and user interface (ui) pcb assemblies.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.

• 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: 3961764
• MDR Text Key: 4557322
• Report Number: 3015876-2014-00860
• 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: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2006
• 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