MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 3 CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

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

Patient Problem Bone Fracture(s) (1870)

Event Date 04/01/2021

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.Patient fields in which information is not provided were intentionally left blank.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the european parliament and of the council.

Event Description

A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient's chest cage had collapsed and had broken ribs.The patient associated with the reported event did not survive.

Manufacturer Narrative

A physio-control sales rep confirmed that the serial number associated with the reported event is sn (b)(6).Section d1 and d4 have been updated accordingly.

Event Description

A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient's chest cage had collapsed and had broken ribs.The patient associated with the reported event did not survive.

Manufacturer Narrative

Stryker evaluated the customer's device and observed no device malfunction.The reported issue could not be verified.After performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.The cause of the reported issue could not be determined, however broken ribs and sternal fracture is a side affect of cpr and the use of the lucas device.Per the oi, the stabilization straps should be used in each event.It is unknown if the straps were used during this patient event.If they weren't, that could have contributed to the reported patient outcome.

Event Description

A customer contacted physio-control to report that some injuries associated with resuscitation were noted at post-mortem of the patient.It was observed that the patient's chest cage had collapsed and had broken ribs.The patient associated with the reported event did not survive.

• Brand Name: LUCAS 3 CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 11814258
• MDR Text Key: 250268989
• Report Number: 0003015876-2021-01044
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K062401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: UNK_LUN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death