MAUDE Adverse Event Report: JOLIFE AB 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 Problem Hemothorax (1896)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the available information, there is no indication of a device malfunction or a use error associated with the reported event.Physio 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

It was reported to physio-control that a lucas chest compression system was used on a patient in cardiac arrest.The patient had return of spontaneous circulation (rosc) after approx.25 minutes of cpr.Five days after the event a computed tomography (ct) thoracic scan was done for a suspected pulmonary infection.The ct scan showed a right-sided pleural effusion with atelectasis (collapsed lung) that hindered the cessation of assisted ventilations.The hemothorax was treated with pleural draining (chest tube).The customer reported that the use of the device may have caused or contributed to the patient's respiratory failure.The patient's outcome was not reported.There was patient use associated with the reported event however, the patient outcome was not reported.

Manufacturer Narrative

The patient's age was reported as being (b)(6).The initial medwatch indicated (b)(6).The outcome of the patient was also reported - the patient survived the reported event.A clinical review of the reported issue was performed by (b)(4) and physio-control with the following feedback/conclusions: there is limited information about this case and no information about the cause of the cardiac arrest or comorbidities.The reported complication of atelectasis and hemothorax occurs during manual cpr in about 0.6% - 1% of the reported cases.It is not possible to definitively determine if the complications were related to the cardiac arrest, comorbidities or by manual or mechanical cpr.However, with the information provided it is possible that (b)(4) compressions contributed to the reported thoracic complications.As described in the scientific literature, the risk of complications from cpr never outweighs the benefit of return of spontaneous circulation.Knowing the risks is important for treatment issues after rosc, because both manual and mechanical cpr may lead to injuries.Paradis, n., et al., cardiac arrest, chapter: manual cardiopulmonary techniques.Second edition ed.2007, cambridge: cambridge university press.576-577.Platenkamp et al, complications of mechanical chest compression devices.Neth heart j.2014 sep; 22(9): 404¿407.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevägen 17; ideon science park; lund SE 22 3 70; SW SE 223 70
• Manufacturer (Section G): JOLIFE AB #3005445717; scheelevägen 17; ideon science park; lund 22370 ; SW 22370
• Manufacturer Contact: jason march ; 11811 willows road ne; po box 97006; redmond 98052
• MDR Report Key: 5523960
• MDR Text Key: 41086166
• Report Number: 3015876-2016-00339
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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: 3302430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/23/2016
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening
• Patient Age: 75 YR