MAUDE Adverse Event Report: ECOLAB / MICROTEK DOMINICANA, S.A. VENODYNE COMPRESSION SLEEVE

Model Number	V3012-FC
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the compression system and the sleeve were returned and analyzed.The compression system was tested with a test sleeve and functioned with no alarms.The sleeve were tested and the compressor system would not reach the desired pressure.The vent holes were measured using pin gauge and the sleeves were found to be within current specification.The sleeves were inflated and submerged in water.No leaks were detected around the seams of the sleeves, but air was observed at the vent holes on the sleeve.
Event or Problem Description
It was reported that during multiple uses, the alarm system would continually sound off.It was noted that this has occured during surgeries and the compression system or sleeves cannot be replaced.The surgeries were continued without therapy.No patient complications have been reported as a result of this event.

• Brand Name: VENODYNE COMPRESSION SLEEVE
• Common Device Name: COMPRESSION SLEEVE
• Manufacturer (Section D): ECOLAB / MICROTEK DOMINICANA, S.A.; zona franca no. 2; la romana, ; DR
• MDR Report Key: 8137428
• Report Number: 8043817-2018-40014
• Device Sequence Number: 950256
• Product Code: JOW
• UDI-Device Identifier: 50748426036238
• UDI-Public: 50748426036238
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V3012-FC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1