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

Model Number	295251
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress at this time.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the device was blowing sockets when plugged in.No patient was harmed.Additional information received stated it appears that the unit tripped a distribution panel.The main lead had been pulled from the device and this may have caused the panel to trip as a current/voltage spike could have resulted during the accidental disconnection.Upon evaluation on 25-jan-2021, the power cord was observed to have burn marks.
Additional Manufacturer Narrative
The service history record was reviewed: the unit was returned 1 time for a different issue related to the device.The unit was 100% functional at the time of last release.Upon inspection and incoming testing, the power cord is burnt and is unable to charge the device.The power cord was changed, the device is working properly and passed the final test.No other physical damage could be seen on the device.The issue of the device blowing sockets cannot be confirmed.The device was working according to the specification.The device was disassembled, no damage could be seen on the components.

• Brand Name: SCD 700 COMPRESSION SYSTEM-UK
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11263228
• Report Number: 1282497-2021-09882
• Device Sequence Number: 4069399
• Product Code: JOW
• UDI-Device Identifier: 10884521129580
• UDI-Public: 10884521129580
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 295251
• Device Catalogue Number: 295251
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/07/2021
• Patient Sequence Number: 1