MAUDE Adverse Event Report: OSCOR INC. CARDIOTRONIC XI EXTENSION CABLE; ELECTRODE CABLE

Model Number XI.MDT

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.There are (b)(4) complaints related to this extension cable from the same end user.Of the (b)(4) reported events, only ten cables were returned to perform an analysis.As the lot number of any cables was not available, it cannot be determined which cable was used in each reported event.The analysis revealed that ten xi.Mdt extension cables were returned from the customer.There were no other accessories.No visible blood was found anywhere on the extension cables.Six black connectors were detached and five red connectors were detached.Due to the condition in which the cables were returned, all cables and detached connectors in one plastic bag, it is impossible to determine which cables go with what connectors.Cable 1: cable returned with red connector separated from device.The resistance through the black connector was not stable and could not be confirmed.After removing strain relief it was found that the black connector is still attached to the wire.The solder joint on the black connector was not completely filled.The red connector separated due to wire break near solder joint.Cable 2.Cable returned with red connector separated from device.The resistance through the black connector is within specification.After removing strain relief it was found that the black connector is still attached to the wire.The solder joint on the black connector was completely filled.The red connector separated due to wire break near solder joint.Cable 3.Cable returned with red connector separated from device.The resistance through the black connector is within specification.After removing strain relief it was found that the black connector is still attached to the wire.The solder joint on the black connector was completely filled.The red connector separated due to wire break near solder joint.Cable 4.Cable returned with red connector separated from device.The resistance through the black connector is within specification.After removing strain relief, it was found that the black connector is still attached to the wire.The solder joint on the black connector was not completely filled.The wire connected to the black connector has broken wire strands and nearing failure.The red connector separated due to wire break near solder joint.Cable 5.Cable returned with black connector separated from device.The resistance through the red connector is within specification.After removing strain relief, it was found that the red connector is still attached to the wire.The solder joint on the red connector was not completely filled.The black connector separated due to wire break near solder joint.Cable 6.Cable returned with black connector separated from device.The resistance through the red connector is within specification.After removing strain relief it was found that the red connector is still attached to the wire.The solder joint on the red connector was completely filled.The wire connected to the red connector has broken wire strands and nearing failure.The black connector separated due to wire break near solder joint.Cable 7.Cable returned with black connector separated from device.The resistance through the red connector is within specification.After removing strain relief it was found that the red connector is still attached to the wire.The solder joint on the red connector was completely filled.The wire connected to the red connector has broken wire strands and nearing failure.The black connector separated due to wire break near solder joint.Cable 8.Cable returned with black connector separated from device.The resistance through the red connector is within specification.After removing strain relief it was found that the red connector is still attached to the wire.The solder joint on the red connector was completely filled.The black connector separated due to wire break near solder joint.Cable 9.Cable returned with black connector separated from device.The resistance through the red connector is within specification.After removing strain relief it was found that the red connector is still attached to the wire.The solder joint on the red connector was completely filled.The black connector separated due to wire break near solder joint.Cable 10.Cable returned with black connector separated from device.The resistance through the red connector is within specification.After removing strain relief it was found that the red connector is still attached to the wire.The solder joint on the red connector was completely filled.The wire connected to the red connector has broken wire strands and nearing failure.The black connector separated due to wire break near solder joint.Conclusion: all cables were returned with one of the two connectors detached and separated from the device.The connectors still attached to the cable are all below the 1 ohm max for resistance through the cable.The failure is occurring at the exposed portion of the wire that is soldered to the pin.Mechanical forces applied to this area of exposed wire is causing the exposed wire to weaken and eventually break.A corrective and preventive action has been initiated to address this failure.Associated mdrs: 1035166-2016-00036 to 1035166-2016-00063 inclusive.

Event Description

The customer reported breakage of this extension cable during use.There was no report of patient injury related to this event.

• Brand Name: CARDIOTRONIC XI EXTENSION CABLE
• Type of Device: ELECTRODE CABLE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer Contact: jan flegeau ; 3816 desoto blvd.; palm harbor, FL 34683-1618 ; 7279372511
• MDR Report Key: 5544496
• MDR Text Key: 41773985
• Report Number: 1035166-2016-00045
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: XI.MDT
• Device Catalogue Number: XI.MDT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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