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 10/28/2014

Event Type  malfunction  

Event Description

The customer, a biomedical engineer, contacted physio-control to report that during a recent patient event the display on their device had a white display.A white display is indicative of a potential device lockup condition.The patient was sedated and being prepared for synchronized cardioversion when the issue occurred.A backup device was quickly obtained and used to continue patient care.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

(b)(4): physio-control examined the customer's device but was unable to duplicate or verify the reported issue.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.

Manufacturer Narrative

As a precaution, physio-control 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.Physio further examined the removed sc pcb assembly and was unable to duplicate the reported white display (lockup) condition.Physio did, however, observe that an integrated circuit (ic) chip, designator u8 would cause the device to boot up with a black screen and only the battery icon showing.The device did deliver defibrillation therapy in this state.Previously physio has seen that a failure of ic chip u8 can cause a lockup condition similar to what the customer had originally reported.The component level cause of the reported issue could not be conclusively determined.The removed ui pcb assembly was an ancillary part and there was no failure of this assembly.

Manufacturer Narrative

The supplemental medwatch report indicates: as a precaution, physio-control 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.Physio further examined the removed sc pcb assembly and was unable to duplicate the reported white display (lockup) condition.Physio did, however, observe that an integrated circuit (ic) chip, designator u8 would cause the device to boot up with a black screen and only the battery icon showing.The device did deliver defibrillation therapy in this state.Previously physio has seen that a failure of ic chip u8 can cause a lockup condition similar to what the customer had originally reported.The component level cause of the reported issue could not be conclusively determined.The removed ui pcb assembly was an ancillary part and there was no failure of this assembly.The supplemental medwatch report should indicate: as a precaution, physio-control 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.Physio further examined the removed sc pcb assembly and was unable to duplicate the reported white display (lockup) condition.Physio then examined the removed ui pcb assembly and did observe that an integrated circuit (ic) chip, designator u8 would cause the device to boot up with a black screen and only the battery icon showing.The device did deliver defibrillation therapy in this state.Previously physio has seen that a failure of ic chip u8 can cause a lockup condition similar to what the customer had originally reported.The component level cause of the reported issue could not be conclusively 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: 4274476
• MDR Text Key: 5028420
• Report Number: 3015876-2014-01404
• 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,Followup
• Report Date: 10/28/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/19/2014; 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2006
• 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