MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; CARDIAC COMPRESSOR

Model Number RMU-1000

Device Problem Product Quality Problem (1506)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

Although requested, the electronic log files from the device were not returned and no specific device or event information was provided.Defibtech is continuing to attempt to gather additional information so that an investigation can occur.Should additional information become available a follow-up mdr will be submitted.

Event Description

A professional customer reported that the device can result in pneumothorax and even tension pneumothorax in patients.No additional event or patient information was provided.

Manufacturer Narrative

Analysis of the log files from the device did not identify a device malfunction.The device functioned properly as designed.As stated in the device user manual, rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.After resuscitation, all patients should be reassessed and re-evaluated for resuscitation-related injuries.

• Brand Name: LIFELINE
• Type of Device: CARDIAC COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 741 boston post road; suite 201; guilford CT 06437
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 12605834
• MDR Text Key: 275883956
• Report Number: 3003521780-2021-00019
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RMU-1000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other