HUDSON ADULT ISO-GARD DRAIN
Received Aug 29, 2016 · Event occurred Aug 22, 2016
Report 8040412-2016-00178 · MDR key 5910767
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, TEN PIECES OF THE SAME CATALOG NUMBER WERE SELECTED FROM CURRENT PRODUCTION AT THE MANUFACTURING FACILITY. A VISUAL EXAM WAS PERFORMED AND NO DEFECTS WERE OBSERVED ON THE SAMPLES. IN ADDITION, ALL TEN PIECES PASSED A LEAK TEST. IN THE CURRENT MANUFACTURING PROCEDURE, 100% LEAK TESTING IS CONDUCTED AT THE ASSEMBLY AREA; THUS, ANY DEFECTS WOULD BE DETECTED PRIOR TO RELEASE. THE COMPLAINT COULD NOT BE CONFIRMED AS THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION, AND NO VISUAL OR FUNCTIONAL ISSUES WERE FOUND ON THE SAMPLES TAKEN FROM PRODUCTION.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE VALVE OF THE DEVICE LEAKS WHICH CAUSES WATER TO SPIT OUT AND LOSE VOLUME FROM THE VENTILATOR. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
(B)(4). THE RESULTS OF THE INVESTIGATION ARE INCOMPLETE AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE VALVE OF THE DEVICE LEAKS WHICH CAUSES WATER TO SPIT OUT AND LOSE VOLUME FROM THE VENTILATOR. NO PATIENT INJURY REPORTED.