MAUDE Adverse Event Report: JOLIFE AB LUCAS (T) CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 3302430

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 05/20/2013

Event Type  Injury  

Event Description

It was reported to a physio-control business development manager that a patient had a puncture wound in the chest following the use of a device for automated cpr.The patient was a (b)(6).The patient's tissue was exposed and the sternum was visible.The patient was found in pulseless electrical activity (pea) cardiac arrest on the arrival of the ambulance crew.The crew then applied the device for automated cpr on the patient.The device's suction cup was attached during the entire event, it did not come off and it was intact after the event.The device's stabilization straps were not used, as they were missing.The wound was discovered when the patient was moved to the ambulance.The crew then started manual cpr.The patient was not resuscitated.

Manufacturer Narrative

(b)(4), evaluated the device but could not observe any malfunctions of the device.Proper device operation was observed through functional and performance testing and after unrelated repairs were performed, the device was returned to the customer for use.The customer reported that their investigation of the issue has concluded that the likely cause of the laceration to the patient was due to a failure to use the device stabilization strap (because it was missing) in conjunction with the device not being paused as the patient was being moved onto the "scoop" which lead to the device slipping off the patient's chest (sternum) and causing the tearing laceration.Replacement stabilization straps have been provided to the customer.Additional training regarding device use has also been offered.Physio-control performed a clinical review of the reported event and determined that use error of the device likely caused the injury of the patient.This report has been previously reported by physio-control, inc.Under manufacturer report# 3015876-2013-00511.

• Brand Name: LUCAS (T) CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB; scheelevagen 17,; ideon science park; lund 223 70; SW 223 70
• Manufacturer Contact: malin melander ; scheelevagen 17; ideon science park; lund 223 7-0 ; SW 223 70 ; 462865011
• MDR Report Key: 3926100
• MDR Text Key: 4581949
• Report Number: 3005445717-2014-00004
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/27/2014

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: 3302430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 05/21/2013
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2010
• 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): Disability
• Patient Age: 75 YR