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

Model Number LUCAS

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Death (1802)

Event Date 08/05/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Stryker evaluated the customer's device and was unable to duplicate the reported issue.After performing an unrelated repair,proper device operation was observed.The device was subsequently returned to the customer for use.The cause of the reported issue could not be determined.Stryker completed a clinical review and determined that the device use may have contributed to the patient outcome, as the interruption in cpr was one minute.The users did not follow the instructions for use that state if there are interruptions, to remove the device and start manual chest compressions.By following the instructions for use the interruption in cpr is likely to be short, not, as in this case, as long as one minute.

Event Description

The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.

Manufacturer Narrative

This mdr was incorrectly submitted with the incorrect fda registration number.Please reference mfr report # 3005445717-2020-00003 for the complete report.

Event Description

The customer contacted stryker to report that their device would not work during a patient event.The device indicated the battery was fully charged, however the device did not operate.The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed.Eventually, the device was removed from the patient and manual cpr was provided.When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes.The device subsequently operated correctly.The interruption in cpr was estimated to be approximately 1 minute.It was delayed due to decision making around transporting without a lucas, while it was being charged.The patient did not survive the reported event.

• Brand Name: LUCAS(R) 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): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 8956384
• MDR Text Key: 156308105
• Report Number: 0003015876-2019-01465
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2019,03/26/2020

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: 99576-000033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Distributor Facility Aware Date: 08/05/2019
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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: 71 YR
• Patient Weight: 80