MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMPRESSION SYSTEM; SLEEVE, LIMB, COMPRESSIBLE

Model Number	9525
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested but to date has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the ot nurse noticed that the power cord is burnt before using the device.The photo provided by the customer indicated evidence of arcing on the power cord closest to where it plugs into the device.
Additional Manufacturer Narrative
Additional information h2, h3, h6 investigation conclusion the customer reported that the ot nurse noticed the power cord was burned prior to use on a patient.The reported product has no service history and was manufactured in 2010.As part of the manufacturing process, all device history records (dhr) are reviewed and approved by quality prior to the release of product to market.A trend analysis was performed and no related adverse trends were identified.The reported product was not returned for evaluation; however, photographs were provided.Examination of the photographs confirmed the report of burt cord, however, the cause cannot be determined.A potential root cause is associated with the age of the product.It is suspected that the power cord becomes old and worn over time and end wires may shift or break loose, which may lead to the cord appearing burnt when connected to a power source.Risk management documentation was reviewed to compare documented vs actual rate of occurrance and was deemed acceptable.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11148718
• Report Number: 1282497-2021-09842
• Device Sequence Number: 17012273
• Product Code: JOW
• UDI-Device Identifier: 10884521081826
• UDI-Public: 10884521081826
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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
• Device Model Number: 9525
• Device Catalogue Number: 9525
• 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: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown