MAUDE Adverse Event Report: CARDINAL HEALTH SCD 700 CONTROLLER - ANZ; SLEEVE, LIMB, COMPRESSIBLE

Model Number	295255
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that while cleaning the theater, the electrical cord shorted, caught fire, sparked, and smoked.The wall panel alarmed, indicating a hazardous electrical fault.They called spotless to verify.After one minute, the device threw a flame, smoked, and had a loud bang.There was no patient in the theater at the time of the incident.The machine was plugged in, but it was not turned on.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
No service history available.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Upon investigation, it was determined that the power cord used in the incident was not an oem part.The use of a non-oem power cord could have contributed to compatibility issues or did not meet the safety and quality standards required for the scd 700 controller.The flexible power cord displayed signs of extensive wear and tear.Repeated bending of the cord can cause the internal insulation to degrade over time.In this case, the insulation breakdown led to exposed wires within the cord, creating the conditions necessary for a short circuit.The short circuit resulted in the cord overheating, which in turn caused the fire and smoke described in the reported incident.A corrective action is not applicable at this time.This complaint will be used for qa tracking and trending purposes.

• Brand Name: SCD 700 CONTROLLER - ANZ
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19627287
• Report Number: 1423537-2024-00050
• Device Sequence Number: 7400551
• Product Code: JOW
• UDI-Device Identifier: 10884521129597
• UDI-Public: 10884521129597
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 295255
• Device Catalogue Number: 295255
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown