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

Model Number 700

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2016

Event Type  malfunction  

Event Description

The scd power cord under the bracket comes loose and disconnected while staying under the bracket.This is causing the device to run on battery and then stop working without notice.Clinical engineering has to remove the bracket, push the end of the power cord into the socket 2 mm and then the unit recognizes the power cord and charges the battery.The form insert under the bracket over time is becoming thin and compressed causing the power cord end to slide out.

• Brand Name: KENDALL SCD
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6085679
• MDR Text Key: 59386630
• Report Number: 6085679
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2016
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1