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

Model Number LUCAS

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

Patient Problem Pain (1994)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Physio-control performed a clinical review of the reported event and determined that user error contributed to the serious injury of the patient.The patient had his arm strapped to the device with the patient straps during the prolonged resuscitation.This resulted in compartment syndrome to the patient's left hand.User error.

Event Description

Physio-control was made aware of the article "compartment syndrome of the hand as a complication of prolonged mechanical cardiopulmonary resuscitation" published in anaesthesia reports 2020-8, that mentioned a patient event where the device use had potentially caused compartment syndrome in a (b)(6) year-old male patient during mechanical cardiopulmonary resuscitation.Cardiopulmonary resuscitation along with aggressive rewarming achieved return of spontaneous circulation.Despite preservation of neurological function the patient died of complications from the cardiac arrest after an extended intensive care unit stay.

Event Description

Physio-control was made aware of the article "compartment syndrome of the hand as a complication of prolonged mechanical cardiopulmonary resuscitation" published in anaesthesia reports 2020-8, that mentioned a patient event where the device use had potentially caused compartment syndrome in a 45-year-old male patient during mechanical cardiopulmonary resuscitation.Cardiopulmonary resuscitation along with aggressive rewarming achieved return of spontaneous circulation.Despite preservation of neurological function the patient died of complications from the cardiac arrest after an extended intensive care unit stay.

Manufacturer Narrative

Section f10 / h6 medical device problem code of the initial medwatch report indicated: use of device problem section f10 / h6 medical device problem code of the initial medwatch report should indicate: adverse event without identified device or use problem.The device was not returned for evaluation.It was determined through the clinical review that the user did not follow the operating instructions.The root cause was determined to be use-error and no device malfunction was reported.

• Brand Name: LUCAS 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: 9981507
• MDR Text Key: 191868428
• Report Number: 3005445717-2020-00006
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/23/2020,10/14/2020

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?: No
• Device Operator: No Information
• Device Model Number: LUCAS
• Device Catalogue Number: UNK_SMP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1