MAUDE Adverse Event Report: JOLIFE AB LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 99576-000025

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

Patient Problems Death (1802); Perforation of Vessels (2135)

Event Date 12/08/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for evaluation.There was no report of a device malfunction.Physio performed a clinical review of the information that was reported.The information that was provided was very limited.The following are the conclusions from the clinical review:  lucas performs compressions according the guidelines for manual cpr with a depth of 5 cm and a rate of 100-120 compressions per minute.The described complication, in this case, is known in the published scientific literature.Injuries to the heart and great vessels occur in about 11% in conjunction with manual cpr. with the limited information it is very difficult to confirm the cause of the patient's outcome.The dissected coronary vessel could be related to the initial cardiac arrest.It could also be a user error or due to compressions by mechanical cpr as mentioned in the report.Therefore, it is possible that mechanical chest compressions may have contributed to the reported patient's outcome.Footnote 1.Paradis, n., et al., cardiac arrest, chapter: manual cardiopulmonary techniques.Second edition ed.2007, cambridge: cambridge university press.576-577.(b)(4).

Event Description

The customer contacted physio-control to report that they had used their lucas® 2 chest compression system to perform automated cpr on a patient.Although the resuscitation initially seemed successful, the patient expired.The patient reportedly suffered from a perforated / dissected coronary blood vessel.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; ideon science park; scheelevägen 17; lund 223 7 0; SW 223 70
• Manufacturer (Section G): JOLIFE AB # 3005445717; ideon science park; scheelevägen 17; lund 223 7 0; SW 223 70
• Manufacturer Contact: todd bandy ; 11811 willows rd ne; redmond, WA ; 4258674000
• MDR Report Key: 6235944
• MDR Text Key: 64238166
• Report Number: 3015876-2017-00031
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2017

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 Catalogue Number: 99576-000025
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/13/2016
• Device Age: 5 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2017
• Date Device Manufactured: 09/22/2011
• 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; Life Threatening; Required Intervention
• Patient Age: 81 YR