MAUDE Adverse Event Report: JOLIFE AB - 3005445717 LUCAS 2, 2.2, IN SHIPPING BOX, EN; 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

This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under mfr # 0003015876-2020-00891.Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with all the available patient information.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.

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 2, 2.2, IN SHIPPING BOX, EN
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16224428
• MDR Text Key: 307904820
• Report Number: 3005445717-2023-00020
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• 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: 06/29/2020
• 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: 82 YR
• Patient Sex: Male