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

Model Number 29525

Device Problems Cut In Material (2454); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Upon triage the service tech found the pump to have a damaged power cord with exposed copper wires.

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 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
• 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 ; 5084514252
• MDR Report Key: 7611672
• MDR Text Key: 111440453
• Report Number: 3006451981-2018-00455
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 07/02/2018
• Date Device Manufactured: 02/25/2015
• 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
• Patient Outcome(s): Other