MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 1000 DEFIBRILLATOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number 1000

Device Problems Device Inoperable (1663); Invalid Sensing (2293)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2014

Event Type  malfunction  

Event Description

It was reported to a physio-control service representative that the customer tried to download the electronic patient record from their device but was unable to do so.The device continued to prompt to push the ¿analyze¿ button, and eventually gave a ¿no shock advised¿ prompt, although no electrodes had been connected to the device.Upon a first evaluation of the device it was observed that the device was locked up, and would not charge and shock defibrillation energy when required.

Event Description

It was reported to a physio-control service representative that the customer tried to download the electronic patient record from their device but was unable to do so.The device continued to prompt to ush the 'analyze' button, and eventually gave a 'no shock advised' prompt, although no electrodes had been connected to the device.Upon a first evaluation of the device it was observed that the device acted as if a patient was connected when no patient cable was connected to the device and that it would not charge and shock defibrillation energy when required.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified the reported failure.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

Physio-control further evaluated the device and observed that the analog pcb assembly acted like a patient was connected at all times.Physio-control further evaluated the analog pcb assembly and determined that the cause of the reported failure was due to a solder splash that shorted legs 7 and 8 of the integrated circuit, designator u27 on the analog pcb assembly.This caused the analog pcb assembly to react as if a patient cable was connected at all times.A replacement device was provided to the customer under warranty.

Manufacturer Narrative

The initial medwatch report indicates: it was reported to a physio-control service representative that the customer tried to download the electronic patient record from their device but was unable to do so.The device continued to prompt to ush the 'analyze' button, and eventually gave a 'no shock advised' prompt, although no electrodes had been connected to the device.Upon a first evaluation of the device it was observed that the device was locked up, and would not charge and shock defibrillation energy when required.The initial medwatch report should indicate: it was reported to a physio-control service representative that the customer tried to download the electronic patient record from their device but was unable to do so.The device continued to prompt to ush the 'analyze' button, and eventually gave a 'no shock advised' prompt, although no electrodes had been connected to the device.Upon a first evaluation of the device it was observed that the device acted as if a patient was connected when no patient cable was connected to the device and that it would not charge and shock defibrillation energy when required.Catalog number of the initial medwatch report indicates: 320371500.Catalog number of the initial medwatch report should indicate: 3203715.(b)(4).Physio-control evaluated the device and verified the reported failure.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.The initial medwatch report should indicate: (b)(4).Physio-control evaluated the device and verified the reported failure.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) 1000 DEFIBRILLATOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• 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: 3694554
• MDR Text Key: 4259110
• Report Number: 3015876-2014-00307
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K042404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2014

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: 1000
• Device Catalogue Number: 3203715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 03/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2014; 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2013
• 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