Model Number LUCAS 2 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Internal Organ Perforation (1987)
|
Event Date 08/05/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
|
|
Event Description
|
It was reported to physio-control that the use of a lucas 2 chest compression system led to broken ribs and a punctured lung in a patient.The punctured lung was discovered post mortem by the county coroner.The coroner reported that the patient had not experienced any kind of trauma (prior to the use of the lucas device) which would have caused a punctured lung.The patient did not survive the event; however, there is no indication that the reported injuries contributed to the patient's death.No further details about the patient or the event were provided.
|
|
Manufacturer Narrative
|
The customer was unable to identify which of their device's had been used in the reported event; therefore, the customer decided to return all three (3) of their devices for evaluation.Physio-control evaluated all 3 (three) of the customer's devices (serial numbers (b)(4)).Proper device operation was observed through functional and performance testing. the devices were then returned to the customer for use. the cause of the reported injuries was not conclusively determined, however the reported injuries are consistent with injuries that are known to be associated with both manual and mechanical chest compressions.
|
|
Search Alerts/Recalls
|