TRANSPORT INCUBATOR 500 GLOBETROTTER

Additional Manufacturer Narrative

THE INVESTIGATION HAS STARTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2024 THE TRANSPORT INCUBATOR 500 (TI500) GLOBE TROTTER HAD AN ISSUE WITH THE TEMPERATURE ADJUST BUTTON AND THE VENTILATOR HAD AN ISSUE MAINTAINING PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS INSPECTED AND SERVICED BY DRAEGER ENGINEERING AND FOUND THAT THE REPORTED PROBLEMS ONLY OCCURRED INTERMITTENTLY. THE ISSUE RELATED TO THE UNRESPONSIVE TEMPERATURE ADJUST BUTTON WAS CONFIRMED DURING DRAEGER'S INSPECTION OF THE DEVICE. DRAGER SERVICE FOLLOWED SERVICE SOFTWARE FOR REPAIR INSTRUCTIONS AND REPLACED THE TEMPERATURE CONTROLLER TO RESOLVE THE ISSUE. THE CUSTOMER'S CONCERN WITH THE VENTILATOR NOT HOLDING PRESSURE WAS NOT ABLE TO BE REPRODUCED DURING SERVICE. THE DEVICE WAS TESTED AND CONFIRMED TO HAVE BEEN OPERATING PER THE MANUFACTURER'S SPECIFICATIONS.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ON (B)(6) 2024 REGARDING A TRANSPORT TI500 GLOBETROTTER THAT DID NOT RESPOND TO THE TEMPERATURE ADJUST BUTTON. THE CUSTOMER ALSO EXPRESSED CONCERNS WITH THE VENTILATOR NOT HOLDING PRESSURE. THE DEVICE WAS IN USE WHEN THE ISSUE OCCURRED, HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER REGARDING THIS EVENT. THE CUSTOMER CONFIRMED THAT THERE WERE NO ALARMS WHEN THE ISSUE OCCURRED AND THE ISSUE WITH THE TEMPERATURE ADJUST BUTTON WAS INTERMITTENT. THE ISSUE WITH THE VENTILATOR WAS ONLY OBSERVED ONCE. FURTHER INFORMATION REGARDING THE STATUS OF THE PATIENT WAS REQUESTED BUT NOT PROVIDED. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT PREVENTATIVE MAINTENANCE HAD NOT BEEN PERFORMED ON THIS DEVICE. ON (B)(6) 2024 THE DEVICE WAS SERVICE BY DRAEGER. THE REPORTED PROBLEM WITH THE VENTILATOR WAS UNABLE TO BE REPLICATED, HOWEVER THE ISSUE WITH THE TEMPERATURE ADJUST BUTTON WAS CONFIRMED. THE DRAEGER SERVICE REPAIR INSTRUCTIONS WERE FOLLOWED TO REPAIR THE DEVICE AND REPLACEMENT PARTS WERE ORDERED. ON 16OCT2024 THE TEMPERATURE CONTROL PANEL ASSEMBLY WAS REPLACED ALONG WITH THE OVERLAY FRONT PANEL. FOLLOWING THE REPAIR, THE DEVICE WAS TESTED AND CONFIRMED TO OPERATE PER THE MANUFACTURER'S SPECIFICATION. THE UNIT WAS HANDED BACK TO THE CUSTOMER FOR CLINICAL USE. IT WAS NOTED THAT IF THE VENTILATION ISSUE WERE TO RECUR AND COULD BE DUPLICATED, THE VENT WOULD BE SENT TO BIOMED SERVICES FOR EVALUATION. THE INSTRUCTIONS FOR USE (IFU), SECTION 4, "INSTALLATION AND FUNCTIONAL CHECKOUT," INSTRUCTS THE USER TO ENSURE PROPER FUNCTION OF THE DEVICE PRIOR TO BEING PUT INTO CLINICAL USE AND SECTION 6, "CLEANING, MAINTENANCE, AND REPLACEMENT PARTS," PROVIDES GUIDANCE FOR THE USER TO PERFORM PREVENTATIVE MAINTENANCE AT THE SPECIFIED INTERVALS. THE IFU STATES THAT PNEUMATIC MODULE SHOULD HAVE PREVENTATIVE MAINTENANCE PERFORMED EVERY 12 MONTHS. A SPECIFIC ROOT CAUSE FOR THE INTERMITTENT FAULT OF THE TEMPERATURE ADJUST BUTTON AND THE VENTILATOR COULD NOT BE CONFIRMED IN THIS INVESTIGATION. A REPLACEMENT OF THE TEMPERATURE CONTROL ASSEMBLY AND THE OVERLAY FRONT PANEL RESOLVED THE REPORTED ISSUE.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT THE ON (B)(6) 2024 THE TRANSPORT INCUBATOR 500 (TI500) GLOBE TROTTER HAD AN ISSUE WITH THE TEMPERATURE ADJUST BUTTON AND THE VENTILATOR HAD AN ISSUE MAINTAINING PRESSURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS INSPECTED AND SERVICED BY DRAEGER ENGINEERING AND FOUND THAT THE REPORTED PROBLEMS ONLY OCCURRED INTERMITTENTLY. THE ISSUE RELATED TO THE UNRESPONSIVE TEMPERATURE ADJUST BUTTON WAS CONFIRMED DURING DRAEGER'S INSPECTION OF THE DEVICE. DRAGER SERVICE FOLLOWED SERVICE SOFTWARE FOR REPAIR INSTRUCTIONS AND REPLACED THE TEMPERATURE CONTROLLER TO RESOLVE THE ISSUE. THE CUSTOMER'S CONCERN WITH THE VENTILATOR NOT HOLDING PRESSURE WAS NOT ABLE TO BE REPRODUCED DURING SERVICE. THE DEVICE WAS TESTED AND CONFIRMED TO HAVE BEEN OPERATING PER THE MANUFACTURER'S SPECIFICATIONS.