MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Catalog Number 97401-000001

Device Problem Gas/Air Leak (2946)

Patient Problem Chemical Exposure (2570)

Event Date 05/23/2006

Event Type  Injury  

Manufacturer Narrative

Reference original medwatch report - 3105876-2007-00406 for the initial reported event.The customer did not release the battery pack to physio control for evaluation.Physio control reviewed battery safety information with the reporter.The battery pack label instructs users, "to dispose of this battery properly, discharge completely by driving blade of screwdriver down into slot as indicated." also, according to the lifepak 500 aed's operating instructions, after placing the tip of a flat-tipped screwdriver on the slot, use a hammer to, "strike a moderate blow straight down on the top of the screwdriver handle.Make sure that the tip of the screwdriver breaks the label and penetrates approximately 3 mm (1/8 inch).This will strike an internal pin, initiate full discharge, and permanently disable the battery." physio-control performed an evaluation of the reported event and determined that the reported event is considered a serious injury. the user was discharging the battery when it vented.The user received medical intervention for respiratory distress to preclude permanent impairment or permanent damage to the lungs.

Event Description

The customer initially reported this event on medwatch 3015876-2007-00406.This initial medwatch included information about all three affected firefighters; however, no additional medwatch reports had been submitted for two of the three firefighters (one per individual).¿ the following is the event description: the customer reported that they had removed a depleted battery pack (part number 3005380-026, lot code unknown) from their aed device.They completed the discharge of the battery pack per the label on the battery.A firefighter used a straight slot screwdriver and the soft handle on a pair of pliers to drive the screwdriver through the label.The battery was then placed in a receptacle in the bay for disposal.The on-duty crew walked into the bay a little later and noted the sulfur smell and a cloud around the receptacle.The crew put on protective gear and removed the battery from the receptacle.They noted the battery had a hole in the side.The battery pack was secured.Three firefighters complained of "itchy skin and respiratory distress" and were treated for exposure to the chemicals from the battery with breathing treatments, steroids, and chest x-rays.One was hospitalized overnight for observation and released the next day.That next day, the reporter stated that all firefighters present at the incident were "okay." in the u.S., epa and dot regulations allow disposal of lithium batteries with ordinary household waste provided that they are fully discharged.

• Brand Name: LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne - po box; redmond WA 98073 9706
• Manufacturer Contact: todd bandy ; 4258674000
• MDR Report Key: 6714320
• MDR Text Key: 80058567
• Report Number: 3015876-2017-00863
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 97401-000001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Manufacturer Received: 09/13/2007
• Date Device Manufactured: 12/31/1997
• 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
• Patient Outcome(s): Required Intervention