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

Model Number	RMU-1000
Medical Device Problem Codes	Sparking (2595); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that when they took it out the arm to use it on a patient, it wasn't needed so they decided to do some training.They reported that they may have forcibly removed or pulled on the charging cable resulting in damage to the connector due to the poor handling by the staff.When they plugged it in, the nurse got a shock.The nurse was uninjured and no one else was injured.This did not occur during patient use.
Additional Manufacturer Narrative
The distributor's customer examined the electrical wire and noticed that a piece was missing.The distributor reviewed pictures of the power cord that the customer had sent, and the pictures suggest the cable has been forcibly removed or pulled resulting in damage from poor handling by the staff.The ifu states: improper maintenance can cause the defibtech rmu series accs not to function as designed.Maintain the acc only as described in the user manual and operating guide.The available information does not reasonably suggest that the device did not perform as intended or failed to meet product specifications at the time it was shipped to the customer.This device is used for treatment, not diagnosis.Should additional information become available a follow-up mdr shall be submitted.
Event or Problem Description
The customer reported that when they took it out the arm to use it on a patient, it wasn't needed so they decided to do some training.They reported that they possibly forcibly removed or pulled on the charging cable resulting in damage and ultimately poor handling from staff.When they plugged it in, the nurse got a shock.The nurse was uninjured and no one else was injured.The reported event did not occur during patient use.
Additional Manufacturer Narrative
The distributor's customer examined the electrical wire and noticed that a piece was missing.The distributor reviewed pictures of the power cord the customer had sent to him and the pictures suggest the cable has been forcibly removed or pulled resulting in damage and ultimately poor handling from the staff.The ifu states: improper maintenance can cause the defibtech rmu series accs not to function as designed.Maintain the acc only as described in the user manual and operating guide.The available information does not reasonably suggest that the device did not perform as intended or failed to meet product specifications at the time it was shipped to the customer.This device is used for treatment, not diagnosis.Should additional information become available a follow-up mdr shall be submitted.

• Brand Name: LIFELINE
• Common Device Name: 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.; 14 commercial st.; branford CT 06405
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 19346978
• Report Number: 3003521780-2024-00501
• Device Sequence Number: 2581723
• Product Code: DRM
• UDI-Device Identifier: 10815098020628
• UDI-Public: 10815098020628
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RMU-1000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown