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

Model Number 295251

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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 fan and a damaged power cord with exposed copper.

Manufacturer Narrative

An evaluation of the scd700 was performed and the customer¿s reported condition was confirmed and it was noted the unit had a damaged power cord with exposed copper.The device was cleaned and disinfected according to manufacturer's guideline.The power cord has exposed copper wires and was replaced.The device was fully checked for functionality and patient electrical safety according to manufacturer's guideline.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: 7406806
• MDR Text Key: 104682487
• Report Number: 3006451981-2018-00265
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521129580
• UDI-Public: 10884521129580
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

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: 295251
• Device Catalogue Number: 295251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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