MAUDE Adverse Event Report: CARDINAL HEALTH KENDALL DL ADAPTER PHILIPS 3 5 LD; CABLE, ELECTRODE

Model Number	33507
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 (false/inaccurate reading, asystole and artifact) on a patient when using the device during a trial during the week of (b)(6) 2022.The patient had external pacing wires from cardiac surgery that came from operating room.The wires are showing and connect to a small box for pacing.When hooked back up to the reusable, they did not have false tracings like asystole or artifact.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 200 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: KENDALL DL ADAPTER PHILIPS 3 5 LD
• 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: 14854330
• Report Number: 1282497-2022-10698
• Device Sequence Number: 4807968
• Product Code: IKD
• UDI-Device Identifier: 20884527021472
• UDI-Public: 20884527021472
• 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): 07/08/2022

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: 33507
• Device Catalogue Number: 33507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown