MAUDE Adverse Event Report: COVIDIEN Kendall SCD

Model Number U29525

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/29/17.An investigation is currently under way; upon completion the results will be forwarded.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 reports that the unit is going off program.During triage at the service center, the technician found damaged power cord with exposed copper wires.

Manufacturer Narrative

The scd 700 was evaluated and the review showed that the unit had a damaged power cord, with copper wire was exposed.From the area in which the damage occurred it is possible this could be related to wear over time from the wrapping procedure of the cord around the bed hook.The cause of the reported condition for the damaged power cord was due to wear from potential wrapping technique overtime.A review of the device history record shows that this unit was manufactured and 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.

• Brand Name: Kendall SCD
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6678283
• MDR Text Key: 79001792
• Report Number: 3008361498-2017-05240
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1