MAUDE Adverse Event Report: PHYSIO-CONTROL LIFE PACK 12

Model Number LIFE PACK 12

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2013

Event Type  malfunction  

Event Description

While attempting to get a 12 lead, v1 continuously didn't work on multiple 12 leads.No injury to patient.

• Brand Name: LIFE PACK 12
• Type of Device: LIFE PACK 12
• Manufacturer (Section D): PHYSIO-CONTROL; redmond WA 98052
• MDR Report Key: 3670331
• MDR Text Key: 4343559
• Report Number: MW5034837
• 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: Other
• Device Model Number: LIFE PACK 12
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2014
• Patient Sequence Number: 1
• Patient Age: 49 YR