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

Model Number 019-540

Device Problems Device Issue (2379); Connection Problem (2900)

Patient Problem Cardiac Arrest (1762)

Event Date 07/12/2017

Event Type  malfunction  

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 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.

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 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)
• Type of Device: PATIENT CABLE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: bill kilby ; 5206 asbury road; farmingdale, NJ 07727 ; 7329382266
• MDR Report Key: 6784843
• MDR Text Key: 82886224
• Report Number: 2242056-2017-00003
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 10841291105282
• UDI-Public: 10841291105282
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 019-540
• Device Catalogue Number: 019-540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention