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

Catalog Number UNK_LUN

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

Patient Problems Laceration(s) (1946); Liver Laceration(s) (1955)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Initial reporter phone field in which information is not provided was intentionally left blank.A clinical review was performed by physio and determined that manual cpr or the use of the device may have contributed to capsular liver tear.Injuries to the liver happens during both manual and mechanical cpr and there are no significant differences in the incidence of liver injuries.Physio-control 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

Physio-control was made aware of the article "major liver trauma post-mechanical cardiopulmonary resuscitation- first reported case of survival with normal cardiovascular and neurological outcome" published in oxford medical case reports 2020;4, that mentioned a patient event where the device use had potentially caused capsular liver tear in a (b)(6) years old male post cardiopulmonary resuscitation.The patient associated with the reported event was immediately taken for a hepatic surgical repair.The patient survived with good neurological outcome and was discharged from hospital nine days later.

Manufacturer Narrative

The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to physio-control for evaluation.The reported issue could not be verified and the cause of the reported issue could not be determined.

Event Description

Physio-control was made aware of the article "major liver trauma post-mechanical cardiopulmonary resuscitation- first reported case of survival with normal cardiovascular and neurological outcome" published in oxford medical case reports 2020;4, that mentioned a patient event where the device use had potentially caused capsular liver tear in a 54 year-old male post cardiopulmonary resuscitation.The patient associated with the reported event was immediately taken for a hepatic surgical repair.The patient survived with good neurological outcome and was discharged from hospital nine days later.

• 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: 10217785
• MDR Text Key: 203343238
• Report Number: 3005445717-2020-00007
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K173553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LUN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR