MAUDE Adverse Event Report: COVIDIEN DISPOSABLE DUAL CON LEAD SET; CABLE, ELECTRODE

Model Number	33136BT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.The results will be shared upon completion.
Event or Problem Description
The customer reported that cdh telemetry is having consistent issues with the leads and mx40 adapters causing inconsistent tracings.There was no patient harm.Additional information provided stated that the leads were providing inconsistent readings, showing "leads off", and providing false alarms.There was no impact to the patient as a result of the inconsistent readings.It is hard for the customer to pinpoint exactly what the issue is as they sometimes switch the adapters and sometimes switch the leads out.The issue is not occurring with every lead set.It was noted that the telemetry boxes sometimes go bad where the adapters connect so the pins sometimes degrade.The customer further stated that by keeping the adapters attached to the monitors, they think they are seeing improved tracings.It is unknown if the leads/adapters are causing the issues.
Additional Manufacturer Narrative
Additional information: d4 lot number.The lot number was determined through the return of the product for evaluation.Evaluation summary: the lot number was not known by the customer; however, the lot number was determined from the returned sample.The device history record (dhr) review for this lot number did not indicate any exception that could lead to the reported incident.There were no process changes on production after checking the entire process: including injection parameters, tooling, and injection equipment.Two samples were received at the manufacturing plant for evaluation with lot number 060799.Testing was performed for the current and insulation.Electrical testing was implemented for 5 wire combinations: ll, rl ra, la, v.The returned cable passed the electrical testing.The welding quality of the connector was checked by x-ray.From the x-ray result, there is no issue found for welding.From the investigation it was determined the returned cable function is normal.Electrical testing was performed on product that was stored in the manufacturing sites warehouse.All products passed the electronic testing.Because no issue was found with the returned samples, the root cause could not be determined.No action is being taken at this moment.This complaint will be used for tracking and trending purposes.

• Brand Name: DISPOSABLE DUAL CON LEAD SET
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10900257
• Report Number: 1282497-2020-09662
• Device Sequence Number: 19198139
• Product Code: IKD
• UDI-Device Identifier: 10884521212602
• UDI-Public: 10884521212602
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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
• Operator of Device: No Information
• Device Model Number: 33136BT
• Device Catalogue Number: 33136BT
• Device Lot Number: 060799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1