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U.S. Department of Health and Human Services

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

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JOLIFE AB LUCAS (T) CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL Back to Search Results
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.
 
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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 Key3926100
MDR Text Key4581949
Report Number3005445717-2014-00004
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K090422
Number of Events Reported1
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 Number3302430
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Device Age3 YR
Event Location Outpatient Treatment Facility
Initial Date Manufacturer Received 05/21/2013
Initial Date FDA Received07/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age75 YR
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