MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS 3, 3.1, IN SHIPPING BOX, EN; 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  

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.

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

Section d10 returned to manufacturer on of supplemental medwatch report 001 was blank.Section d10 returned to manufacturer on of supplemental medwatch report 001 should indicate: 10/03/2019.

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 3, 3.1, IN SHIPPING BOX, EN
• 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: 9258145
• MDR Text Key: 164881602
• Report Number: 0003015876-2019-01741
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019,04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 99576-000063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Distributor Facility Aware Date: 09/25/2019
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1