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

Model Number U29525

Device Problem Cut In Material (2454)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customers report of the pump has a damaged power cord with exposed copper wire.

Manufacturer Narrative

An evaluation of the scd 700 was performed and the customer states the pump has a damaged power cord with exposed copper wire¿ the unit was triaged and the customer¿s reported condition was confirmed.The power cable had physical damage that resulted exposed copper wire.The white and black internal wires were completely severed.The cut appears to be clean in nature.The white and black wires represent neutral and ground.The device also has other minor cutes that to not breach the copper wire.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.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: 7425088
• MDR Text Key: 105423394
• Report Number: 3006451981-2018-00271
• Device Sequence Number: 1
• Product Code: JOW
• 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: 05/01/2018

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: U29525
• Device Catalogue Number: U29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 05/01/2018
• 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