PORTEX 1ST RESPONSE ADULT MANUAL RESUSCITATORS

Additional Manufacturer Narrative

THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED VIA EMAIL STATING THAT THE ISSUE WAS RESOLVED.

Additional Manufacturer Narrative

WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. DHR: AWAITING PRODUCT RETURN TO SMITHS MEDICAL FOR LOT CONFIRMATION.

Description of Event or Problem

IT WAS REPORTED THAT A PT. WAS LEAVING THE OPERATING ROOM IT WAS FOUND THAT 02 WAS NOT FLOWING THROUGH THE AMBU BAG TO THE PATIENT. CRNA ASKED FOR A NEW AMBU BAG AND THE ANESTHESIOLOGIST GOT A NEW ONE. PATIENT TRANSPORTED. NO PATIENT INJURY WAS REPORTED.