MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK TRACK LIGHT MONITOR TROLLY ASSEMBLY

Model Number 029-4856-04

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Midmark's due diligence was made to contact the third-party servicer for the resolution of the service performed on this product.Midmark has documented the multiple attempts for contact within their process.No response has been returned to midmark regarding this matter.

Event Description

This report summarized 1 malfunction event.The 1 event stated that the light post of a track light/monitor came loose and the doctor was able to grab a hold of the post prior to falling.No patient or injury involved.Due to previous reporting of this or similar events, midmark complied to report this instance.

Manufacturer Narrative

Midmark's due dilligence was made to contact the third-party servicer for the resolution of the service performed on this product.Midmark has documented the multiple attempts for contact within their process.No response has been returned to midmark regarding this matter.

Event Description

This report summarized 1 malfunction event.The 1 event stated that the light post of a track light/monitor came loose and the doctor was able to grab ahold of the post prior to falling.No patient or injury involved.Due to previous reporting of this or similar events, midmark complied to report this instance.

• Brand Name: MIDMARK TRACK LIGHT MONITOR TROLLY ASSEMBLY
• Type of Device: TRACK LIGHT MONITOR
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda baker ; 60 vista drive; versailles, OH 45380 ; 9375267990
• MDR Report Key: 12680478
• MDR Text Key: 284641427
• Report Number: 1523530-2021-00004
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 029-4856-04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• 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