SUPPORT ARM 177

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION AND SERVICE REPORT. BASED ON TECHNICIAN STATEMENT, THE SUPPORT ARM SUDDENLY BROKE DOWN DURING USE. THE SUPPORT ARM WAS FOUND DEFECTIVE AND IT WAS POINTED FOR REPLACEMENT. THE CLIENT HAS CONTACTED A THIRD-PART MAINTENANCE COMPANY TO REPLACE THE SUPPORT ARM AND SOLVE THE PROBLEM. SINCE SERVICE WORK WAS PERFORMED BY THIRD PART COMPANY, NO DETAILS REGARDING WHICH PART OF SUPPORT ARM HAS BEEN BROKEN WAS OBTAINED. THE ISSUE WAS DECIDED TO BE REPORTED AS BROKEN/DAMAGED SUPPORT ARM MAY LEAD TO TO STOP OF VENTILATION (EXTUBATION) OR INJURY. IN ORDER TO CONDUCT FURTHER ANALYSIS OF THE CASE, MORE DETAILED INFORMATION IS REQUIRED. UNFORTUNATELY, NEITHER PHOTO OF DAMAGE NOR THE CLAIMED PART WAS AVAILABLE FOR FURTHER ANALYZE. THEREFORE, THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).