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

Model Number	29525
Medical Device Problem Codes	Cut In Material (2454); Split (2537)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Upon triage the service tech found the pump to have a damaged power cord with exposed copper wires.
Additional Manufacturer Narrative
The scd 700 was evaluated for the reported condition of, ¿the pump has a damaged case¿.The unit was triaged and the customer¿s reported condition was confirmed and it was found that there was exposed copper wires on the unit's power cord.Power cord was inspected and a cut was found on the outer insulation.Approximately 2 inches of the internal wiring was pulled out of the cut creating a loop.The internal white wire had insulation damage, exposing copper.The internal black wire had insulation and wire damage, exposing internal copper.The pump was excessively damaged, so the root cause is categorized as customer misuse.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports the pump has a damaged case.Upon triage the service tech found the pump to have a damaged power cord with exposed copper wires.

• Brand Name: KENDALL SCD
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7611672
• Report Number: 3006451981-2018-00455
• Device Sequence Number: 157057
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2025
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other