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

Model Number RMU-1000

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Although requested on 10/21/2019, 11/1/2019 and 11/18/2019, additional event and device information was not provided and the electronic data from the device was not returned.Little is known about the event and the root cause is not currently known.Should additional information become available, a follow-up mdr will be submitted.

Event Description

During a trade show, a customer stopped by with a complaint about the device.Ultimately, they stated they loved the unit, but reported a traumatic event where a patient, who had cardiac surgery 5 or so years ago and had a fully healed scar down his chest, received chest injury, leaving an open wound, after receiving mechanical cpr.The patient outcome was not known.As stated in the device user manual section 1.5 side effects, the international liaison committee on resuscitation (ilcor) states the following side effects of cpr: "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." (from the 2005 international consensus conference on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations, hosted by the american heart association in dallas, texas, january 23-30, 2005.Published in circulation.2005; 112: iii-5-iii-16.) the above side effects, as well as bruising and soreness of the chest, may commonly occur after the use of the rmu-1000 acc.(black cj, busuttil a, robertson c.Chest wall injuries following cardiopulmonary resuscitation.Resuscitation.2004 dec;63(3):339-43.).

• 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: roberto cunha ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 9343306
• MDR Text Key: 167198850
• Report Number: 3003521780-2019-00021
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2019

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: No Information
• Device Model Number: RMU-1000
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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