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

Model Number LUCAS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The cause of the reported injury was not conclusively determined; however the reported injury is consistent with injuries that are known to be associated with cardio pulmonary resuscitation.  in the lucas instruction for use it is written, skin abrasions, bruising and soreness of the chest are common during the use of the lucas chest compression system.Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device caused extensive trauma to patients, with one incident involving a sternal fracture which resulted in cardiac laceration.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

Manufacturer Narrative

Physio-control evaluated the customers device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that their device caused extensive trauma to patients, with one incident involving a sternal fracture which resulted in cardiac laceration.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

Manufacturer Narrative

Outcomes attributed to adverse event of the initial medwatch report should indicate: other serious (important medical events).

Event Description

The customer contacted physio-control to report that their device caused extensive trauma to patients, with one incident involving a sternal fracture which resulted in cardiac laceration.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.

• Brand Name: LUCAS¿ CPR CHEST COMPRESSION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL / DRM
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; ideon science park; redmond WA 98052
• MDR Report Key: 9219427
• MDR Text Key: 163201829
• Report Number: 0003015876-2019-01728
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• PMA/PMN Number: K161768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2019

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: Health Professional
• Device Model Number: LUCAS
• Device Catalogue Number: UNK_LUN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 11/29/2019; 11/25/2019
• Supplement Dates FDA Received: 12/02/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other