XLTEK EEG/PSG DELL OPTIPLEX 5050 SMALL FORM FACTOR SYSTEM

Additional Manufacturer Narrative

UPDATE 20TH APRIL 2020 (NATUS COMPLAINT REF. # (B)(4)). INVESTIGATION RESULTS & FINDINGS: UPDATE RECEIVED ON THE 06TH MARCH 2020 INDICATED THAT 03-06-20 THE NURSE ROLLED THE CART INTO THE ELEVATOR WHEN THE EXTENSION FELL OVER DURING TRANSIT FROM ON FLOOR TO ANOTHER. NO INJURIES OCCURRED. UPDATE ON THE 09TH APRIL - THE FIELD TECH CONFIRMED THE PART HAD BEEN REPAIRED UNDER SERVICE TICKET (B)(4). THE FIELD SERVICE TECH INDICATED THE VIDEO ASSEMBLY CAME OFF THE POLE. THE FIELD SERVICE TECH REPLACED THE VIDEO ASSEMBLY ONSITE AND ALSO RELOADED SLEEPWORKS ON TWO CARTS. COMPLAINT VERIFIED, RESOLVED ON-SITE AND NO FURTHER ACTION NECESSARY. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. NO DEATH OR SERIOUS INJURY. THIS EVENT IS CONSIDERED A CUSTOMER INCONVENIENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW. THIS ISSUE WILL BE CONTINUED TO BE MONITORED.

Description of Event or Problem

CUSTOMER REPORTED THE UPPER CART BROKE HITTING A NURSE.

Additional Manufacturer Narrative

SERVICE TECH DOCUMENTED IN SIEBEL THE CUSTOMER REPORTED THE UPPER CART BROKE HITTING A NURSE. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION: NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED.: DATE OF EVENT: DATE OF EVENT REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT YET PROVIDED RELEVANT TESTS / LABORATORY DATA: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS: NOT APPLICABLE SERIAL #: THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. IF IMPLANTED DATE (MM/DD/YYYY): THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY): THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS: THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE: USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT): THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE FOR USE BY USER FACILITY / IMPORTER: NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF ND, GIVE PROTOCOL #: THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS: THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. IF REMEDIAL ACTION INITIATED, CHECK TYPE: THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER: THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

Description of Event or Problem

XLTEK EEG/PSG DELL OPTIPLEX 5050 SMALL FORM FACTOR SYSTEM SERVICE TECH DOCUMENTED IN SIEBEL THE CUSTOMER REPORTED THE UPPER CART BROKE HITTING A NURSE.