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

Model Number 295251

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reports that the unit has a damaged power cord with copper exposed.

Manufacturer Narrative

An evaluation of the scd 700 compression system was performed for the reported condition of, ¿the unit has a damaged power cord with copper exposed¿.The unit was triaged and service confirmed the reported issue.The power cord was replaced.Device fully checked for functionality and patient electrical safety according to manufacturer's guideline.Power cords periodically require replacement due to age, usage and user damage.Kinking of the cable assembly along the cord length, which is indicative of being tightly wrapped around the bed hook has been identified as a contributing factor for this failure mode.Over time, tightly wrapping of the cord around the bed hook causes a constant tension to be applied to the outer cover resulting in the cover being milked out of the strain relief.Stretching the power cord at a sharp angle to the plug to reach the wall outlet has the same effect.Therefore the potential root cause for this issue is customer misuse.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.

Manufacturer Narrative

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: 7689614
• MDR Text Key: 114285212
• Report Number: 3006451981-2018-00507
• 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

• Date FDA Received: 07/16/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1