MAUDE Adverse Event Report: PHYSIO CONTROL LIFEPACK 12

Model Number LIFEPACK 12

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

Attempted to transmit 12 lead and it would not go through.No injury to patient reported.

• Brand Name: LIFEPACK 12
• Type of Device: LIFEPACK 12
• Manufacturer (Section D): PHYSIO CONTROL; redmond WA 98052
• MDR Report Key: 3670335
• MDR Text Key: 19299204
• Report Number: MW5034842
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2014

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: LIFEPACK 12
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR