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

Model Number RMU-1000

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

Patient Problems Death (1802); Injury (2348)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Although requested, the unit serial number and the electronic history files from the unit have not been provided.The investigation remains open and no root cause is currently known.Should additional information become available, a follow-up mdr will be submitted.

Event Description

On february 2, 2017 it was reported by a professional user (an emt) that during a rescue attempt on a (b)(6) year old patient in cardiac arrest, the device caused a serious injury to the chest of the patient where the device was positioned after approximately two minutes of use.They further reported that they stopped using the device; put a towel on the patient, and starting performing manual chest compressions.They reported that although the patient was not resuscitated, the device did not cause or contribute to the death of the patient.The initial reporter is seeking additional information regarding the nature of the reported injury and said he would provide us with that information.

• Brand Name: LIFELINE
• Type of Device: EXTERNAL 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: ed horton ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 6378210
• MDR Text Key: 69105763
• Report Number: 3003521780-2017-00005
• 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,health professional
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Model Number: RMU-1000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• 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
• Patient Age: 102 YR
• Patient Weight: 79