MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 2.0 MAINFRAME; ELECTROMYOGRAPH, DIAGNOSTIC

Model Number 8252001IP

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

No devices are being returned for evaluation.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

It was reported by engineering at the user facility that "the staff was having a problem with the large 25 pin connector that attaches to the back, they must move it to get it to work.I'm not sure if it is the connector on the back or the cable." follow-up with the initial reporter learned the device is not being returned for repair as they are upgrading their system and he did not have any further information about the event.It is unknown if this occurred during a case.No injury was reported.

Manufacturer Narrative

Corrected information:no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® 2.0 MAINFRAME
• Type of Device: ELECTROMYOGRAPH, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 5555398
• MDR Text Key: 42166493
• Report Number: 1045254-2016-00111
• Device Sequence Number: 1
• Product Code: IKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8252001IP
• Device Catalogue Number: 8252001IP
• Device Lot Number: 58815400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1