MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPACK 20; DEFIBRILLATOR

Model Number LIFEPAK 20

Device Problem Pacing Problem (1439)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 09/19/2014

Event Type  Injury  

Event Description

A (b)(6) yr old female comes into the hosp being paced due to severe bradycardia.She is switched from the ems pacer to covenant's pacer machine which passed shift checks the day of this event.The pacer system was working and the pt had been on the device from 10 - 20 mins when the device performed a self test in the middle of pacing the pt and then shut off causing the pt to go into cardiac arrest.Cpr performed for about 6 mins when pulse obtained and was able to be placed back on another pacer that was functioning properly.Pt was intubated for a few days and now is off the ventilator and has had a permanent pacemaker placed.If the initial pacer device would have continued to pace the pt would not have coded.Device is available at covenant for manufacturer to check but not releasable at this time to return to the company.Our biomed has been in contact with physio-control concerning this event.

• Brand Name: LIFEPACK 20
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; po box 97006; redmond WA 98073 970
• MDR Report Key: 4156408
• MDR Text Key: 4928272
• Report Number: 4156408
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2014
• Distributor Facility Aware Date: 07/19/2014
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR