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

Model Number	33135T
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the icu monitor read crazy rhythms when using the device.The customer stated they changed out the products without resolution.When they put the patient back on the reusable lead, the issue was resolved.Additional information received on 1-jun-2022 stated that the products provided a false/inaccurate reading.No patient injury reported.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as the affected lot number was not provided by the customer.However, the supplier reviewed the dhr records for the last three lots, and did not find any change to material, tooling, process, procedure, or machine parameters.The customer reported that no samples will be returned for evaluation therefore the supplier randomly checked 500 pieces from inventory and rechecked the functional test under current mass production test conditions; no issues were found.Based on the available information, the reported issue could not be confirmed.Furthermore, since the supplier performs 100% functional test prior to product release, it does not appear that the reported issue is related to the manufacturing process.No corrective and preventative actions are required at this time.If a sample is received at a later date, the investigation will be updated accordingly.This complaint will be used for tracking and trending purpose.

• Brand Name: 5 LD DISPOSABLE DUAL CON SYST
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14566577
• Report Number: 1282497-2022-10694
• Device Sequence Number: 5095532
• Product Code: IKD
• UDI-Device Identifier: 10192253019261
• UDI-Public: 10192253019261
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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
• Device Model Number: 33135T
• Device Catalogue Number: 33135T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 06/16/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown