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

Model Number	295250
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
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 had a burnt/melted power cord, additional information was received stating that there were no patient harm.
Additional Manufacturer Narrative
H3 evaluation summary: no service history was available because this was the first time this unit was returned to the service center for service.A burnt/melted power cord was received at the service center.Pictures were also provided for evaluation.The reported issue was seen on the returned power cord.The reported condition was confirmed.This type of burning can not necessarily be linked to a power cord non-conformity.If the current was too high, then the whole cable would show damage.In this case, only the connector started to heat and melt.A nonconforming wall socket could cause this damage.The power cord was repaired and passed safety testing.A corrective and preventative action (capa) is not applicable at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD 700 COMPRESSION SYSTEM-EUR
• 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: 12855896
• Report Number: 1282497-2021-10657
• Device Sequence Number: 17353584
• Product Code: JOW
• UDI-Device Identifier: 10884521129573
• UDI-Public: 10884521129573
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/03/2022

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: 295250
• Device Catalogue Number: 295250
• Device Lot Number: WC0000033268
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown