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

Model Number SMHF-06D

Device Problem Material Integrity Problem (2978)

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

Event Date 07/10/2020

Event Type  malfunction  

Event Description

It was reported that the table sheets did not have enough grip to hold the patients position and three patients had slipped on the table while using the table sheet from the convenience kit.One patient was placed in a deep trendelenburg and the patient was observed sliding off the table.The table sheets were used as a positioner and off label use was conducted.No patient complications have been reported as a result of this event.

• Brand Name: CLEANOP INFECTION CONTROL SYSTEM
• Type of Device: TABLE SHEET
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL; 1 ecolab place; st paul, mn
• Manufacturer Contact: anuli okolo-young ; 1 ecolab place; st paul, mn ; 2502237
• MDR Report Key: 10368181
• MDR Text Key: 202782141
• Report Number: 1043582-2020-00007
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMHF-06D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Device Usage: Initial
• Patient Sequence Number: 1