MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD; SLEEVE, LIMB, COMPRESSIBLE

Model Number 95251

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Upon triage it was noted that the power cord has exposed copper wires.

Manufacturer Narrative

An evaluation of the scd express was performed for the reported condition of, ¿exposed green wires and an alarm issue¿.Upon follow up the customer reported "the wire¿s were exposed" the unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured and was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 7369794
• MDR Text Key: 103440246
• Report Number: 3008361498-2018-00153
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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 Model Number: 95251
• Device Catalogue Number: 95251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1