MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Catalog Number 99576-000026

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Using the information provided by the customer, (b)(4) performed a clinical review of the reported event.(b)(4) determined that the device use may have contributed to the patient's outcome, noting that rib fractures and other injuries are known to be associated with both manual and mechanical chest compressions.(b)(4) continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted (b)(4) to report their device had been used during a patient event and the patient did not survive.Later the (b)(6) informed stryker that the device was initially used during the transportation of a (b)(6) woman to the hospital and was able to revive the patient five times.Upon reaching the hospital, the device was used again to provide cpr for approximately 30 minutes.The patient subsequently did not survive and the autopsy result concluded that there was trauma to the heart that could have been caused by the device.Patient associated with the reported event did not survive.Stryker contacted the customer in order to obtain additional event details; however, no response was received.

Manufacturer Narrative

Physio-control received additional information about the police investigation of the reported incident.The police informed that the patient underwent an autopsy which concluded that the patient suffered from a chronic disease which affected the tissue of the heart to be porous and fragile.The police and autopsy did not conclude the lucas 2 to be causing the woman¿s death.Using the new information provided, physio-control performed a clinical review.It was determined that the lucas device did not contribute to the patient's outcome.Section h6 has been updated from adverse event to no known impact or consequence to the patient.Stryker evaluated the customer's device.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.

Event Description

The customer contacted physio-control to report their device had been used during a patient event and the patient did not survive.Later the danish medicines agency (dma) informed stryker that the device was initially used during the transportation of a 43 year old woman to the hospital and was able to revive the patient five times.Upon reaching the hospital, the device was used again to provide cpr for approximately 30 minutes.The patient subsequently did not survive and the autopsy result concluded that there was trauma to the heart that could have been caused by the device.Patient associated with the reported event did not survive.Stryker contacted the customer in order to obtain additional event details; however, no response was received.

• Brand Name: LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• MDR Report Key: 8425234
• MDR Text Key: 138946075
• Report Number: 0003015876-2019-00443
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K090422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 99576-000026
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 43 YR