MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER EXAM TABLE; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number 104

Device Problem Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Patient received a burn when a vaginal speculum was removed from healing drawer in exam table.Patient quickly alerted provider of warmth of instrument and instrument was removed.Table was turned off and equipment removed.The exam table is a ritter model 104 purchased in feb 2001, asset # (b)(4).Tables are inspected annually, next due for inspection feb 2023.The temperature of drawer was reported to be 200 degrees f.

• Brand Name: RITTER EXAM TABLE
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MIDMARK CORPORATION
• MDR Report Key: 16016074
• MDR Text Key: 305980623
• Report Number: MW5113861
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Female