MAUDE Adverse Event Report: PHYSIO-CONTROL PHYSIO-CONTROL LP15 MONITOR; LIFEPAK 15

Model Number LP 15

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 03/02/2017

Event Type  malfunction  

Event Description

Physio-control lp15 monitor shut down during arrest.

• Brand Name: PHYSIO-CONTROL LP15 MONITOR
• Type of Device: LIFEPAK 15
• Manufacturer (Section D): PHYSIO-CONTROL; redman WA
• MDR Report Key: 6390810
• MDR Text Key: 69571983
• Report Number: MW5068349
• Device Sequence Number: 1
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2017

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: LP 15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2017
• 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: 50 YR