MAUDE Adverse Event Report: PHYSIO CONTROL LUCAS; NONE

Model Number LUCAS 2

Device Problem Fitting Problem (2183)

Patient Problems Death (1802); Tissue Damage (2104)

Event Date 06/06/2015

Event Type  Other  

Event Description

Suction cup on lucas device was not seated correctly.It was noticed after the device was removed after the pt was declared dead that the suction cap had caused soft tissue damage to the anterior chest skin and perhaps muscle layer.The damage was more than is usually noted after lucas removal.

• Brand Name: LUCAS
• Type of Device: NONE
• Manufacturer (Section D): PHYSIO CONTROL; redmond WA 98052
• MDR Report Key: 4856149
• MDR Text Key: 5807331
• Report Number: MW5043116
• Device Sequence Number: 1
• Product Code: DRM
• 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: 06/15/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Device Lot Number: 100582-01
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR