MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSION SYSTEM-JPN; SLEEVE, LIMB, COMPRESSIBLE

Model Number	295257
Medical Device Problem Codes	Arcing (2583); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
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 during inspection, when the power cord was plugged in, sparks flew from the outlet and the 3-pin part of the power cord was burnt.The device started up but it was unable to check the inside of it.The power cord was torn.There was a coating detachment, but no exposed internal copper wire and metal conductor wire.No accessories were affected.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed.The unit was triaged and found to have a damaged power cord, and pressure detection failure.The root cause was determined to be user misuse.The pcba was found to be expired and required replacement.A new power cord is recommended however the customer cancelled the repair.A corrective action is not applicable at this time since the root cause was identified as mishandling of the device by user.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: SCD 700 COMPRESSION SYSTEM-JPN
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11616196
• Report Number: 1282497-2021-10030
• Device Sequence Number: 11525391
• Product Code: JOW
• UDI-Device Identifier: 10884521129603
• UDI-Public: 10884521129603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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
• Operator of Device: No Information
• Device Model Number: 295257
• Device Catalogue Number: 295257
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 09/23/2021
• Patient Sequence Number: 1