MAUDE Adverse Event Report: PHYSIO CONTROL LIFE PACK 12

Model Number LIFEPACK 12

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2013

Event Type  malfunction  

Event Description

While patient on monitor, it shuts off and turned back on.No injury to patient reported.

• Brand Name: LIFE PACK 12
• Type of Device: LIFE PACK 12
• Manufacturer (Section D): PHYSIO CONTROL; redmond WA 98052
• MDR Report Key: 3670338
• MDR Text Key: 4344058
• Report Number: MW5034845
• 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

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIFEPACK 12
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR