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

Model Number 29525

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No specific issue was found in the service or complaint system for the return.Verified technician finding that the power cord was damaged and copper wiring was exposed.A pm/safety label on the front of the unit had the words "frayed cord" written over it in marker.Visual inspection of the cord found a cut in the outer insulation across the cord that had severed the internal black and white wires, exposing the inner copper.Power cord was removed and retained.If information is provided in the future, a supplemental report will be issued.

Event Description

Upon triage, the technician found that the power cord was damaged and copper wiring was exposed.

Manufacturer Narrative

One kendall scd 700 sequential compression system was received with no complaint listed.The unit was triaged and service found that the power cord was damaged exposing copper wires.Visual inspection of the cord found a cut in the outer insulation across the cord that had severed the internal black and white wires, exposing the inner copper.The power cord was replaced.The potential root cause is customer misuse by running over the cord with hospital bed or due to the procedure used to unplug the unit and the procedure of wrapping of the cord around the bed hook.All device history records are reviewed for quality 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
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7564694
• MDR Text Key: 109889254
• Report Number: 3006451981-2018-00413
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2013
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1