MAUDE Adverse Event Report: CARDINAL HEALTH SCD 700 COMPRESSION SYSTEM-UK; SLEEVE, LIMB, COMPRESSIBLE

Model Number	295251
Medical Device Problem Code	Fire (1245)
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 device caught fire during operation at one of their theatres.There were visible burn marks near the point where the main cable connects to the unit.The device is still intact and the event did not require extinguishment.There was no patient harm or involvement.
Additional Manufacturer Narrative
The service history record was reviewed.The unit was previously returned three times for a different failure mode and 100% functional at the time of the last release.The unit was received for investigation and during evaluation, it was observed that the device turned on, but the check valve was leaking, and the bed hook was broken.There are fire/smoke traces on the outside of the device, but no further traces could be found on the inside of the device.There is no evidence of smoke or fire coming from the device itself.The reported condition could not be duplicated or confirmed.The device will be serviced and sent back to the customer.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD 700 COMPRESSION SYSTEM-UK
• 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: 16382238
• Report Number: 1282497-2023-10736
• Device Sequence Number: 5708511
• Product Code: JOW
• UDI-Device Identifier: 10884521129580
• UDI-Public: 10884521129580
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/23/2023

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: 295251
• Device Catalogue Number: 295251
• Device Lot Number: WC0000079315
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown