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

Model Number	29525-
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): burnt.The returned pump s/n: (b)(4) was evaluated.The pump was received in a used condition.The pump was functionally tested and the customer reported issue was not confirmed.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
Event or Problem Description
The customer reported that the power cord burned.

• Brand Name: SCD 700 COMPRESSION SYSTEM-US
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12072920
• Report Number: 1282497-2021-10446
• Device Sequence Number: 14305720
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2021

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: 29525-
• Device Catalogue Number: 29525-
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/26/2021
• Patient Sequence Number: 1