MAUDE Adverse Event Report: CARDINAL HEALTH PERFORMA 2X3.5, 4/PK 5519-68; ELECTRODE, CUTANEOUS

Model Number	EP84113
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
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 therapists were using the electrical stimulation modality on a patient and there was a spark and some smoke at the location of the wire attaching to the pad.Per additional information received, there was no patient harm.
Additional Manufacturer Narrative
Investigation conclusion: the reported complaint stated a therapist was using an electrical stimulation modality on a patient.The therapist noticed a spark and some smoke at the location of the wire and pad attachment.We believe the pad/wire may be faulty.Additional information provided regarding the event impact to patient: there was no harm to the patient.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Product and failure mode trending was reviewed, and no related adverse trends were identified.The process failure modes and effects analysis (pfmea) was reviewed to ensure all risks associated with the product have been identified.A total of ten (10) products were returned for evaluation six (6) pouches were received unopened and four (4) pouches were received opened with unused electrodes.One (1) electrode, included within the four (4) open and unused pouches, contained black spots and was stuck to paper, thus, making it difficult to analyze its electrical properties.Functional evaluation of the returned product was not performed as the product was deemed compromised.The construction of the electrode was examined and met quality specifications.In summary, a review of the equipment, material, manufacturing process and probable root cause of the reported product failure was performed, and the reported product failure was not confirmed.A root cause was unable to be determined, however, it should be noted that the reported product is not intended to be used with a power source.Corrective actions taken were limited to manufacturer awareness.This complaint will be recorded and used for monitoring and trending purposes.

• Brand Name: PERFORMA 2X3.5, 4/PK 5519-68
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): CARDINAL HEALTH; 1313 west grant blvd; wabasha MN 55981
• Manufacturer (Section G): CARDINAL HEALTH; 1313 west grant blvd; wabasha MN 55981
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12848709
• Report Number: 2183164-2021-00150
• Device Sequence Number: 14565923
• Product Code: GXY
• UDI-Device Identifier: 10885914070649
• UDI-Public: 10885914070649
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: Health Professional
• Device Model Number: EP84113
• Device Catalogue Number: EP84113
• Device Lot Number: 035621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown