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

Catalog Number 2010-07381

Device Problems Failure to Reset (1532); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

One side of scd machine keeps beeping foot and cannot reset.

• Brand Name: SCD
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• MDR Report Key: 16408302
• MDR Text Key: 309868480
• Report Number: 16408302
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2022

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 Operator: Health Professional
• Device Catalogue Number: 2010-07381
• Device Lot Number: V1332757SX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1