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

Model Number	295255
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident 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.
Event or Problem Description
The customer reported that a patient was hooked up to the scd compression system when the power cable next to the device side sparked and exploded.The patient was not hurt but power was lost to the device, rcd was not tripped.
Additional Manufacturer Narrative
The scd 700 with sn: (b)(6) was received for evaluation for the first time in the service repair center.The pump was received with a 5m power cord which is not the same type of power cord used or provided for this device therefore it was determined that the customer used their own power cord.The device was visually and functionally tested.Based on the visual inspection, the pump showed no signs of sparks around the iec chassis at the back of the pump which indicates that the spark was not from the inside of the device.A new power cord was attached to the pump and the device was turned on.The software version installed on the pump was 7.01 which is not latest version however the pump worked properly.A performance verification was completed to the manufacturer's specifications and the device passed all the tests.An electrical safety test was then completed and passed.Based on all available information, the device works as designed.The reported issue could not be confirmed.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD 700 COMPRESSION SYSTEM-ANZ
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11762235
• Report Number: 1282497-2021-10141
• Device Sequence Number: 19626402
• Product Code: JOW
• UDI-Device Identifier: 10884521129597
• UDI-Public: 10884521129597
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 295255
• Device Catalogue Number: 295255
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1