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

Model Number 29525

Device Problems Break (1069); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer states the unit has physical damage.Upon triage, the following issue was found: a damaged power cord with exposed copper wiring.

Manufacturer Narrative

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

Manufacturer Narrative

An evaluation of the scd 700 compression system was performed for the reported condition of, ¿the unit has physical damage¿.The unit was triaged and service found that the power cord had exposed copper wires.Upon receipt the unit had a power cord and no other accessories.The unit was able to power up on battery power and pass post with no errors.Visual inspection of the power cord revealed the outer insulation was damaged resulting in exposure of the internal insulated wires.Additionally the insulation was damaged on the black (line) and green (ground) wires, resulting in exposed copper.The insulation has a frayed appearance as if it was run over by a wheel and not as if it was cut with a blade or scissors.Power cords periodically require replacement due to age, usage and user damage.Service noted that the power cord insulation " a frayed appearance as if it was run over by a wheel." based on this observation the potential root cause for this issue is customer misuse.All device history records are reviewed for quality in inspections and parameter compliance prior to releasing the product for shipment.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: 7761650
• MDR Text Key: 116858994
• Report Number: 3006451981-2018-00552
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1