MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS ® CPR 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

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr # 3005445717-2021-00005.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) (b)(4) 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 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 ® CPR 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): 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: 16131640
• MDR Text Key: 307014607
• Report Number: 0003015876-2023-00043
• 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: Distributor
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2021,01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2021
• Distributor Facility Aware Date: 04/13/2021
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2021
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2019
• 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