MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SONY 27 MONITOR; ACCESSORIES,ARTHROSCOPIC

Model Number LMD-2760MD

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the set up before the surgery the sony 27 monitor is powered on, the screen has lines across, as per this issue, the staff was unable to view images.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h3, h6.The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A visual inspection was performed and no deficiencies were observed.A functional test revealed that the monitor powers up but displays red lines in place of an image.The complaint was verified and the root cause was associated with electrical component failure.

• Brand Name: SONY 27 MONITOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10932738
• MDR Text Key: 219373498
• Report Number: 1643264-2020-01983
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 04905524983111
• UDI-Public: 04905524983111
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/02/2021

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: LMD-2760MD
• Device Catalogue Number: 72204860
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 01/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1