MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS ® CPR CHEST COMPRESSION SYSTEM; DRM, COMPRESSOR, CARDIAC, EXTERNAL

Model Number LUCAS

Device Problem Smoking (1585)

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

Event Date 09/18/2022

Event Type  malfunction  

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.   though stryker requested some patient information, stryker will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.A stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.After completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.The clinical review of the reported event was performed and it was concluded that it is likely that the interruption in cpr was short, and the incidence did not contribute to the patient¿s outcome.When the device did not function, the rescuer started manual cpr according to the instruction for use.

Event Description

The customer contacted stryker to report that their device started to smoke when turned on during intervention on a patient.In this state, a delay in cardiopulmonary resuscitation may occur.The patient did not survive reported event.

Manufacturer Narrative

Section h6 health impact code grid of initial mdr indicates: death section h6 health impact code grid of initial mdr should indicate: no health consequences or impact.

Event Description

The customer contacted stryker to report that their device started to smoke when turned on during intervention on a patient.In this state, a delay in cardiopulmonary resuscitation may occur.The patient did not survive reported event.

• Brand Name: LUCAS ® CPR CHEST COMPRESSION SYSTEM
• Type of Device: DRM, COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 15782452
• MDR Text Key: 303534381
• Report Number: 3005445717-2022-00005
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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): Death
• Patient Age: 59 YR
• Patient Sex: Male