MAUDE Adverse Event Report: DEFIBTECH LLC. DEFIBTECH LIFELINE ARM ACC; COMPRESSOR, CARDIAC, EXTERNAL

Model Number RMC-1000 COMPRESSION MODULE

Patient Problem Cardiac Arrest (1762)

Event Date 11/18/2023

Event Type  Injury  

Event Description

The cpr(cardiopulmonary resuscitation) machine left a larger than normal wound to the pt.The wound appeared to be deeper and larger than normal operations.Pt was in cardiac arrest prior to use and post use.

• Brand Name: DEFIBTECH LIFELINE ARM ACC
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): DEFIBTECH LLC.; guilford CT 06437
• MDR Report Key: 18191854
• MDR Text Key: 328914121
• Report Number: MW5148364
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RMC-1000 COMPRESSION MODULE
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White