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

Model Number 295251

Device Problem Cut In Material (2454)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer states a power issue and the power cord has exposed copper wires.

Manufacturer Narrative

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

Manufacturer Narrative

One kendall scd 700 sequential compression system was reported condition of, ¿a power issue and the power cord has exposed copper wires.¿.The unit was triaged and the customer¿s reported condition was confirmed.Unit¿s power cord had exposed copper wiring as well as broken prongs.Thus causing the unit to be unable to turn on.The potential root cause is customer misuse due to the procedure used to unplug the unit.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.

• Brand Name: KENDALL SCD
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7613928
• MDR Text Key: 111487614
• Report Number: 3006451981-2018-00457
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521129580
• UDI-Public: 10884521129580
• 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,Followup
• Report Date: 10/05/2018

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: 295251
• Device Catalogue Number: 295251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/19/2018; 08/08/2018
• Supplement Dates FDA Received: 07/13/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1