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

Model Number	29525
Medical Device Problem Code	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 there was a spark when the device was plugged in.
Additional Manufacturer Narrative
Section b5 was updated with additional information received from the initial reporter.
Event or Problem Description
The customer reported that there was a spark when the device was plugged in.Additional information was provided on 11-may-2022 stating that there was no patient injury and no medical intervention given, no damage to the device caused by sparking and it did not require intervention to extinguish.No further details provided.
Additional Manufacturer Narrative
The device from this complaint was returned and evaluated at the regional service center.The returned unit was received in used condition with no physical damage.The unit was functionally tested and the reported issue of "sparked when plugged in" was not duplicated.The software on the device was verified and is up to date.Based on the available information, a root cause was not able to be determined as the reported issue is unconfirmed.The service history was reviewed for this device and no prior records were found.No corrective and preventive actions are needed at this time.Complaint trending information is reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: SCD 700 COMPRESSION SYSTEM-US
• 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: 14349178
• Report Number: 1282497-2022-10688
• Device Sequence Number: 11992326
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• 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,Followup
• Report Date (Section B): 08/05/2022

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 04/18/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/11/2022; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown