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

Model Number LUCAS

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  Injury  

Event Description

The customer contacted stryker to report that the staff injured her thumb while engaging the device and its backplate.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker performed a clinical evaluation, and the device use may have contributed to the event.Further evaluation of the detail reported, it is reasonable to conclude that the cause of the injury was related to use error and customer training.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Manufacturer Narrative

Stryker evaluated the provided information and determined the root cause of the reported injury is due to use error.H3 other text : device not return.

Event Description

The customer contacted stryker to report that the staff injured her thumb while engaging the device and its backplate.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL / DRM
• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17312934
• MDR Text Key: 318978613
• Report Number: 3005445717-2023-00047
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: UNK_SMP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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): Other