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

Model Number U9525

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reports the pump has a power issue and a damaged power cord with exposed copper wires.

Manufacturer Narrative

One kendall scd express was reported condition of, ¿ pump has a power issue and a damaged power cord with exposed copper wires¿.The unit was triaged and the customer¿s reported condition was confirmed.After a visual inspection of the unit under testing (uut), the power cord was observed to be damaged with exposed copper wire.A known-good power cord was connected to the uut.When the uut was connected to ac, the charging indicator did not illuminate and the device could not power on.The uut was disassembled and the power supply assembly was inspected.L1 was observed to be damaged and the pin connecting negative output pin of the supply board to the power supply board was observed to be broken.The damaged l1 was replaced with a known-good l1 and the astrodyne supply board pin was replaced with a new pin.After repairing the pcba, the board was placed back into the uut.When the device was connected to ac, the charging indicator illuminated and the device could be powered up.The root causes of the reported symptom of no ac power was a damaged l1 inductor and a damaged pin connecting the astrodyne supply board to the power supply board.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: 7556694
• MDR Text Key: 109641919
• Report Number: 3006451981-2018-00408
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521100213
• UDI-Public: 10884521100213
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U9525
• Device Catalogue Number: U9525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• 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