MalfunctionFEN
ABVISER AUTOVALVE IAP MONITORING DEVICE WITH TRANSDUCER, POLE MOUNT
Received Nov 5, 2015
Report 1722554-2015-31256 · MDR key 5205311
Device
Generic name
Device, Cystometric, Hydraulic
Manufacturer
Wolfe Tory Medical IncModel number
ABV331Lot number
120327
Product problems
- Calibration Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem
IT WAS REPORTED THAT PRODUCT DOES NOT ZERO AND WILL NOT GIVE A READING.