MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 01/15/2021

Event Type  Death  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A customer contacted physio-control to report that their device was used during transport and in the emergency room for an hour long cpr.Autopsy showed fractures of the sternum with secondary lacerations of the aorta resulting in bleeding.There was no observed malfunction during the event.The patient did not survive the event, but the customer confirmed this does not mean it was the primary cause of death.

Manufacturer Narrative

The customer contacted physio-control to report that the patient was a 63-year-old male and that the device may have contributed to death.Section b3 has been updated.Physio-control performed a clinical review and determined that it can not be excluded that the injuries were caused by lucas cpr and may have contributed to the patient´s death.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.1,2 in this prolonged cpr case the sternum fracture and secondary laceration of the aorta was confirmed by the pathologist.

Event Description

A customer contacted physio-control to report that their device was used during transport and in the emergency room for an hour long cpr.Autopsy showed fractures of the sternum with secondary lacerations of the aorta resulting in bleeding.There was no observed malfunction during the event.The patient did not survive the event, but the customer confirmed this does not mean it was the primary cause of death.

Manufacturer Narrative

The customer was contacted by stryker, however they could not provide a serial number for the device involved.The customer stated that there was no suspected device failure , however it is alleged that the device caused the serious injury and may have contributed to the death.The device could not be evaluated so no root cause could be determined for the reported patient injury.The device remains with the customer.

Event Description

A customer contacted physio-control to report that their device was used during transport and in the emergency room for an hour long cpr.Autopsy showed fractures of the sternum with secondary lacerations of the aorta resulting in bleeding.There was no observed malfunction during the event.The patient did not survive the event, but the customer confirmed this does not mean it was the primary cause of death.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12131488
• MDR Text Key: 260442995
• Report Number: 0003015876-2021-01383
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS 2
• Device Catalogue Number: 99576-000026
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 08/25/2022
• Supplement Dates FDA Received: 08/23/2021; 09/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 63 YR
• Patient Sex: Male