MAUDE Adverse Event Report: ALTO DEVELOPMENT CORPORATION A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML); PATIENT CABLE

Model Number	019-540
Medical Device Problem Codes	Device Issue (2379); Connection Problem (2900)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded at hospital and is not returning to a and e medical for evaluation.A and e medical quality system documentation (complaints, nonconformces, and device history records have been reviewed).These records do not indicate any trends pertaining to this device and the alleged complaint.There are no other complaints within the a and e medical system.This complaint would appear to be an isolated event.The patient was noted as being paced with this device prior to movement of the patient.It is possible the connector could have been damaged while transporting patient from intensive care unit to operating room.A and e medical will continue to monitor its quality system.
Event or Problem Description
Disposable myo lead cable came unplugged from the pacing box.The patient coded in the cvicu and in the cvor.The connector circumference of the plug was observed having a fracture.The fracture created a "flimsy" interface with the pacing box.
Additional Manufacturer Narrative
Device was discarded at hospital and is not returning to a&e medical for evaluation.A&e medical quality system documentation (complaints, nonconformces, and device history records have been reviewed).These records do not indicate any trends pertaining to this device and the alleged complaint.There are no other complaints within the a&e medical system.This complaint would appear to be an isolated event.The patient was noted as being paced with this device prior to movement of the patient.It is possible the connector could have been damaged while transporting patient from intensive care unit to operating room.A&e medical will continue to monitor its quality system.(b)(4).
Event or Problem Description
Disposable myo lead cable came unplugged from the pacing box.The patient coded in the cvicu and in the cvor.The connector circumference of the plug was observed having a fracture.The fracture created a "flimsy" interface with the pacing box.

• Brand Name: A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML)
• Common Device Name: PATIENT CABLE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 6784843
• Report Number: 2242056-2017-00003
• Device Sequence Number: 132581
• Product Code: IKD
• UDI-Device Identifier: 10841291105282
• UDI-Public: 10841291105282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2017

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
• Operator of Device: Physician
• Device Model Number: 019-540
• Device Catalogue Number: 019-540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention