MAUDE Adverse Event Report: CARDINAL HEALTH 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31.1925.21
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	10/12/2023
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 inaccurate and inconsistent reading from the electrode.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing the product was released accomplishing all quality requirements.No samples nor photos were returned for evaluation.Without the physical samples, the true root cause could not be determined.No corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17994718
• Report Number: 9710060-2023-00216
• Device Sequence Number: 20514622
• Product Code: DRX
• UDI-Device Identifier: 20192253016984
• UDI-Public: 20192253016984
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 31.1925.21
• Device Catalogue Number: 31.1925.21
• Device Lot Number: 23166C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/20/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown