MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD

Model Number 95251

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/27/2017.An investigation is currently underway; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the unit has a damaged cable.On (b)(6) 2017 service notes state that the unit had a damaged power cable and copper wire was exposed.

Manufacturer Narrative

The scd express was evaluated, the unit had a damaged power cable and copper wire was exposed.The cause of the reported condition for the damaged power cord was due to customer misuse, it is commonly noted the for cord to be damaged in the hospital setting from being impacted, dragged or pinched.The power cord was replaced as part of the repair.The device was retested and returned to the customer.The unit passed all testing after repairs were completed.A review of the device history record shows this device was released meeting all manufacturing specifications.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.

Event Description

The customer states that the unit has a damaged cable.On (b)(6) 2017 service notes state that the unit had a damaged power cable and copper wire was exposed.

• Manufacturer (Section D): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6360534
• MDR Text Key: 68760315
• Report Number: 3008361498-2017-05018
• Device Sequence Number: 1
• Product Code: JOW
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95251
• Device Catalogue Number: 95251
• Device Lot Number: V0730306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Date Device Manufactured: 06/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1