CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES

Description of Event or Problem

IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE INDICATOR NEEDLE STOPPED ON THE HALFWAY. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. ONE (1) USED DECONTAMINATED SAMPLE WAS RECEIVED WITH ITS ORIGINAL PACKAGING UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. FUNCTIONAL TEST WAS PERFORMED. THE OUTLET LUER NOZZLE WAS CLOSED BY ONE FINGER AND FLEXIBLE BULB WAS SQUEEZED. IT WAS OBSERVED THAT POINTER WAS BLOCKED NEAR VALUE 70 ON READING PLATE BECAUSE POINTER WAS IN CONTACT WITH GLASS COVER. IT WAS ALSO NOTICED THAT THE GLASS COVER WAS PARTIALLY DISASSEMBLED/CLICKED OUT. THE CUFF INFLATOR WAS FOUND TO BE WORKING WELL WITHOUT ANY POINTER BLOCKING ONCE THE GLASS COVER WAS CLICKED IN. DUE TO FACT THAT THE FAILURE WAS OBSERVED AFTER SOME TIME IN USE, THE MOST PROBABLE CAUSE THAT THIS DEFECT HAPPENED DURING USE OR THE PROBABLE CAUSE WAS DUE TO BEING DROPPED, HIT DAMAGE OR DURING SOME UNAUTHORIZED REPAIR. D5 IS PATIENT/CONSUMER.UNIQUE IDENTIFIER IS UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).