UNOMETER 500 - URINEMETERS
Received Dec 8, 2014 · Event occurred Nov 7, 2014
Report 3007966929-2014-00115 · MDR key 4339664
Device
Generic name
Urine Flow Rate Measuring Non-electr
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
154921
Product problems
- Disconnection
Patient
Unknown
- No Known Impact Or Consequence To Patient
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PAST COUPLE OF MONTHS THE INTENSIVE CARE UNIT STAFF CAME ACROSS DEVICES WHERE THE TUBING DETACHED FROM THE CHAMBER AFTER TRYING TO EMPTY THE URINE INTO THE CHAMBER.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL PATIENT/EVENT INFORMATION BUT, NO INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.