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

Model Number LUCAS

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

Patient Problems Contusion (1787); Death (1802); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 11/16/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device's serial number could not be confirmed by the customer.The device was not returned to physio-control for evaluation.Physio-control performed a clinical review of the provided information and concluded the lucas device performs compressions according to the european resuscitation council guidelines for manual cpr with the recommended depth and rate.The risks of injuries are considered acceptable consequences of cpr given the alternative of death from cardiac arrest.Rib and sternum fractures are known side effects of cpr and are described in the lucas instructions for use.The cervical fracture was likely not caused by cpr.However, it cannot be excluded that the liver laceration/rupture and the thoracic spine fracture may be a consequence of cpr, manual or mechanical although the reported incidence is low.

Event Description

The customer contacted physio-control to report that their device had potentially caused injuries to a patient during a resuscitation.The coroner identified rib fractures, pulmonary contusions, liver lacerations, thoracic spine fracture and cervical spine fracture during the post-mortem examination of the patient.

Manufacturer Narrative

Section d4 model # of the initial medwatch report indicates: blank.Section d4 model #of the initial medwatch report should indicate: lucas.

Event Description

The customer contacted physio-control to report that their device had potentially caused injuries to a patient during a resuscitation.The coroner identified rib fractures, pulmonary contusions, liver lacerations, thoracic spine fracture and cervical spine fracture during the post-mortem examination of the patient.

• 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: 8081626
• MDR Text Key: 127528424
• Report Number: 0003015876-2018-01934
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: 99576-000025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR