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 Tissue Damage (2104)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer was unable to identify which of their two device's had been used in the reported event (serial numbers (b)(4)).  the device was not returned to physio-control for an evaluation since there was no allegation of a product malfunction.The customer stated that the devices worked as intended.The cause of the reported injury was not conclusively determined; however the reported injury is consistent with injuries that are known to be associated with mechanical chest compressions.  in the lucas instruction for use it is written, skin abrasions, bruising and soreness of the chest are common during the use of the lucas chest compression system.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.

Event Description

The customer contacted physio-control to report that the device was used on a (b)(6) old male, who was found unresponsive for approximately 6 to 7 minutes.The lucas 2 device was used on the patient for an unspecified amount of time.The device was removed from the patient's chest and an open wound was observed where the device suction cup had been placed that would most likely require medical intervention.The patient is deceased.The wound exposed what appears to be sternal wires from a prior open-heart surgery. no further details about the patient or the event were provided.The customer, a healthcare provider, stated that the device use did not cause or contribute to the death of the patient.

Manufacturer Narrative

The initial medwatch report indicated that this event was an adverse event and the type of reportable event was a serious injury.After further review, physio-control concluded that the reported injury is not a serious injury due to: not being life threatening; not resulting in permanent impairment of a body function or permanent damage to a body structure; not necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure; permanent is defined as irreversible impairment or damage to body structure or function. .

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevägen 17; ideon science park; 223 70 lund 223 7 0; SW 223 70
• Manufacturer (Section G): JOLIFE AB # 3005445717; scheelevägen 17; ideon science park; 223 70 lund 223 7 0; SW 223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 6730099
• MDR Text Key: 80621946
• Report Number: 3015876-2017-00886
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

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 Model Number: LUCAS 2
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 13 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 08/13/2017
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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): Required Intervention
• Patient Age: 68 YR