MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL IN. CLEANOP INFECTION CONTROL SYSTEM; TABLE SHEET

Model Number SHMC-06

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

It was reported that a patient slid off of the operating room table while in trendelenburg position during robotic case.Patient was not initially strapped/taped to table but was eventually taped on shoulders & torso.There were no patient or staff injuries as a result of the event.

• Brand Name: CLEANOP INFECTION CONTROL SYSTEM
• Type of Device: TABLE SHEET
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL IN.; 1 ecolab place; st. paul, mn
• Manufacturer Contact: steven deline ; 1 ecolab place; st. paul, mn ; 2503744
• MDR Report Key: 10449103
• MDR Text Key: 204227124
• Report Number: 1043582-2020-00008
• Device Sequence Number: 1
• Product Code: KME
• 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: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SHMC-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1