MAUDE Adverse Event Report: MIDMARK CORP. MIDMARK; LIGHT, OPERATING, DENTAL

Model Number 18606

Device Problem Component Falling (1105)

Patient Problem Sprain (2083)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

The monitor and down-tube fell.There was no pt in the room at the time and the monitor was caught by the cables running through the device and personnel in the room.The personnel that caught the device later reported a potential sprain.

Manufacturer Narrative

The monitor down-tube was not returned.Photographic evidence was given showing the connection points.Also, a midmark rep reviewed the site and confirmed that the installation was not originally completed and subsequently had been corrected.The results show that the installation instructions were not followed.There are redundancies built into maintaining the monitor overhead.One that it is threaded into a trolley.In the trolley there are two set screws that are secured into positions to hold the monitor in place.The monitor down tube was not threaded into the trolley.The user manual states that the down tube must be threaded in for proper installation.The set screws were the only thing holding the device up.This was evident by the deformation they caused in the correct location on the device.

• Brand Name: MIDMARK
• Type of Device: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): MIDMARK CORP.; versailles OH
• Manufacturer Contact: craig rammel ; 60 vista dr.; versailles, OH 45380 ; 9375263662
• MDR Report Key: 3881260
• MDR Text Key: 4511367
• Report Number: 1523530-2014-00004
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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