MAUDE Adverse Event Report: COVIDIEN 5 LD DISPOSABLE DUAL CON SYST; CABLE, ELECTRODE

Model Number	33135T
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An investigation is currently underway, the results will be shared upon completion.
Event or Problem Description
The customer reported that after changing all of the adapters, they are still having a lot of problems with the telemetry cables not picking up or giving bad readings.A critical vascular patient was coded because the cables looked like asystole.There was no patient harm reported.Additional information provided by the customer stated that the patient had recently been directly admitted to the icu from the or and was still intubated and sedated.The patient had poor/weak pulses at baseline so when the monitor read asystole and it became difficult to palpate a pulse cpr was initiated briefly.The patient was not shocked (this is not a recommended intervention for asystole) and no meds were given before they realized it was faulty cables.No further medical intervention or follow up care was required.The patient was made cmo by family the next day (unrelated to the malfunction) and has since passed away.After the event the cables were switched out 2-3 times on this patient before they found a set that worked.They were all the same lot number.All of the adapters were changed incase they were causing the issue however, the issues have continued.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The supplier has performed electrical testing on their products in warehouse and the test result is passed.One physical sample was returned for the evaluation.Under current test conditions, the supplier used current fixture to perform the electrical testing on the returned sample.The returned cable did pass the electrical testing.Therefore, the root cause could not be determined.A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 5 LD DISPOSABLE DUAL CON SYST
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10788743
• Report Number: 1282497-2020-09606
• Device Sequence Number: 11635370
• Product Code: IKD
• UDI-Device Identifier: 10884521212596
• UDI-Public: 10884521212596
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 33135T
• Device Catalogue Number: 33135T
• Device Lot Number: 055878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1