MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC PHYSIO. CONTROL; LIFEPAK 10 MONITOR - DEFIBRILLATOR

Model Number LIFEPAK 10

Device Problems Monitor failure (1407); Defibrillation/Stimulation Problem (1573)

Patient Problem Sudden Cardiac Death (2510)

Event Date 08/18/2004

Event Type  malfunction  

Event Description

While servicing a pt on (b)(6) 2004 at approx 0120 hours, one of our ambulance crews had occasion to utilize the defibrillator and pacing functions of listed lifepak 10.The officer on this call reported that, although the batteries in the lifepak were adequately charged, he was unable to charge the defibrillator to the selected 200 joules.While enroute to the receiving hospital, after several attempts were made to correct the problem, the lifepak started to respond and was operational.The lifepak was subsequently removed from service for eval and replaced.This event did not directly effect pt outcome and is reported as an equipment malfunction.

• Brand Name: MEDTRONIC PHYSIO. CONTROL
• Type of Device: LIFEPAK 10 MONITOR - DEFIBRILLATOR
• Manufacturer (Section D): MEDTRONIC; redmond WA 98073
• MDR Report Key: 5200417
• MDR Text Key: 30545358
• Report Number: 5200417
• 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: Other
• Type of Report: Initial
• Report Date: 08/19/2004

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: LIFEPAK 10
• Device Catalogue Number: 804200 - 28
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2004
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2004
• Distributor Facility Aware Date: 08/18/2004
• Event Location: Other
• Date Report to Manufacturer: 08/20/2004
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 136