MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pleural Effusion (2010)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with all the available patient information.Patient fields in which information is not provided were intentionally left blank.The customer's device was not returned to physio-control for evaluation.A clinical review of the reported patient event was performed and concluded the following: from the information provided it can not be understood what the reason was to perform a bilateral pleural decompression.Without that information a determination cannot be made if the device use caused any adverse event to the patient.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that a patient required bilateral pleural decompression post-arrest.There was no report of a device malfunction during use, however the customer had concerns of the cpr device set too deep.

• Brand Name: LUCAS CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 10260950
• MDR Text Key: 198424974
• Report Number: 0003015876-2020-00863
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00883873904565
• UDI-Public: 00883873904565
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• 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): Required Intervention
• Patient Age: 70 YR