HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

COMPLAINT REPORTED THAT: "DURING THE INSPECTION, THE NURSING AREA INDICATE THAT THE MASK WAS BROKEN". NO REPORT OF PATIENT HARM/INJURY.

Additional Manufacturer Narrative

QN#20043605. THE SAMPLES WERE RETURNED AND SENT TO THE MANUFACTURER (GALEMED) FOR INVESTIGATION. GALEMED REPORTS "THE BROKEN CRACKS ARE ALL AT THE CLAMPING LINE OF THE PRODUCTS, AND THE CRACKS ARE RELATIVELY SMOOTH, NO BURR. ALL MASK MUST BE TEST THE LEAKAGE IN PRODUCE PROCESS. OBVIOUSLY, IF THE CRACK IS SO LARGE, IT CANNOT PASS THE LEAKAGE TEST." THE CONCLUSION OF MANUFACTURER IS AS FOLLOWS: "ACCORDING THE ABOVE INFORMATION AND RETURNED SAMPLE, WE SPECULATE THAT THE OPERATOR DID NOT USE THE CORRECT METHOD TO REMOVE BURRS FROM THE PRODUCT DURING THE MANUFACTURING PROCESS. AS A RESULT, THE WELDING STRENGTH OF THE PRODUCT AT THIS POSITION IS REDUCED. HOWEVER, THERE WAS NO IMMEDIATE CRACK IN THE PRODUCTION PROCESS, SO THE LEAK TEST IN THE PLANT WAS QUALIFIED. IN THE PROCESS OF TRANSPORTATION, THE PRODUCT MAY BE SUBJECTED TO LARGE VIBRATION OR IMPACT, RESULTING IN DETERIORATION OR DAMAGE OF THIS POSITION."

Description of Event or Problem

COMPLAINT REPORTED THAT: "DURING THE INSPECTION, THE NURSING AREA INDICATE THAT THE MASK WAS BROKEN". NO REPORT OF PATIENT HARM/INJURY.