MAUDE Adverse Event Report: CARDINAL HEALTH SCD 700 SERIES CONTROLLER FOR WITH US PO; SLEEVE, LIMB, COMPRESSIBLE

Model Number	29525-
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
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 that the device and/or power cord caught on fire once it was plugged into the ac wall unit. when the staff member plugged the device into ac power, the positive voltage was shorted to ground due to the internal failure of the ac plug and wiring.There was a spark and flames that appeared at the plug and wall outlet.They planned on changing the ac power cord and testing the device for function. the staff member was not harmed.The pump did not catch on fire.There was no visible damage on the pump.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD 700 SERIES CONTROLLER FOR WITH US PO
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• 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: 16637176
• Report Number: 1282497-2023-10748
• Device Sequence Number: 17637321
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 29525-
• Device Catalogue Number: 29525-
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown