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

Model Number	9525-
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample 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 sparks were seen from the power cord when the device was running and burning smell was detected.After removing from the power point, a visible burnt spot was discovered on the power cord.
Additional Manufacturer Narrative
All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.The service history record was reviewed and indicated that this is the first time that this unit has been returned for service.The returned device was inspected, and an analysis was performed; upon evaluation, the reported condition is confirmed; however, it was not possible to determine the relationship between the returned device and the cause for this event, as the power cord has been burnt.This is a very old unit, and it was manufactured in the year of 2011.The suspected power cord becomes old and worn over time, end wire begins to break loose caused burnt when connected to the source.Therefore, it cannot be confirmed to be manufacturing-related.At this time, a corrective and preventive action is not deemed necessary.If additional information is received, this file will be re-opened for further investigation.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10942004
• Report Number: 1282497-2020-09762
• Device Sequence Number: 583488
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 9525-
• Device Catalogue Number: 9525-
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1