IP PTZ HD ERGOJUST VIDEO EXTENSION

Additional Manufacturer Narrative

INITIAL REPORT (B)(4). PER (B)(4) REV 83 XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET. HAZARD ID - 6.11 DUE TO MECHANICAL STRESS OR IMPACT, DYNAMIC LOADING, VIBRATION, OR ENVIRONMENTAL CONDITIONS -- ACCESSORY SHELF ON CART MAY BE UNABLE TO SUPPORT THE MASS OF ACCESSORIES OR ITEMS PLACED ON ITS SURFACE, CAUSING IT TO BEND OR BREAK AND LEAVE SHARP EDGES EXPOSED OR BROKEN SUPPORT SYSTEM COULD LAND ON AND HARM SOMEONE. EFFECTS (HARM): CRUSHING INJURY. RESIDUAL RISK - MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. FURTHER INVESTIGATION TO CARRIED OUT.

Description of Event or Problem

IP PTZ HD ERGOJUST VIDEO EXTENSION - ERGOJUST CART CHASSIS BREAKING. METAL ON POLE STARTED TO COMPLETELY SHEAR, MAKE SHIFT REPAIR HAS BEEN DONE TO KEEP IT IN PLACE.

Description of Event or Problem

IP PTZ HD ERGOJUST VIDEO EXTENSION - ERGOJUST CART CHASSIS BREAKING. METAL ON POLE STARTED TO COMPLETELY SHEAR, MAKE SHIFT REPAIR HAS BEEN DONE TO KEEP IT IN PLACE. NO INJURIES.

Additional Manufacturer Narrative

FOLLOW UP REPORT (B)(4). INSTALL DATE OF DEVICE:07-SEP-2022. PER (B)(4) REV 86 XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET. HAZARD ID - 6.11 DUE TO MECHANICAL STRESS OR IMPACT, DYNAMIC LOADING, VIBRATION, OR ENVIRONMENTAL CONDITIONS -- ACCESSORY SHELF ON CART MAY BE UNABLE TO SUPPORT THE MASS OF ACCESSORIES OR ITEMS PLACED ON ITS SURFACE, CAUSING IT TO BEND OR BREAK AND LEAVE SHARP EDGES EXPOSED OR BROKEN SUPPORT SYSTEM COULD LAND ON AND HARM SOMEONE. EFFECTS (HARM): CRUSHING INJURY. RESIDUAL RISK - MEDIUM. THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. INVESTIGATION RESULTS: ONE VIDEO EXTENSION WAS RETURNED WITH BOTH INNER WELDS BROKEN. THE SECONDARY TABS ON BOTH SIDES WERE ALSO BENT AND BROKEN. THESE TABS WERE TESTED TO HOLD 40 LBS IN VERIFICATION. THE INSIDE OF THE MAST ALSO SHOWS SIGNIFICANT WEAR TO THE PAINT, THE PAINT IS WORN THROUGH INDICATING THE MAST WAS ABLE TO MOVE (WOBBLE, ROCK, TILT) ENOUGH THAT THE PAINT WAS COMPLETELY WORN THROUGH INSIDE THE MAST. THE USER WOULD HAVE BEEN ABLE TO SEE THE MAST MOVING BACK AND FORTH WHEN THE CART WAS IN USE AND SHOULD HAVE TAKEN THE CART OUT OF SERVICE. THE CART WAS CONTINUED TO BE USED AND EVENTUALLY THE SECONDARY TABS ALSO FAILED. PER IFU - NATUS ERGOJUST INSTALLATION & FUNCTIONALITY GUIDE (019667 REV 09), PAGE 1-10 STATES "INSPECT THE DEVICE PRIOR TO USE. DO NOT USE IF DAMAGED." ROOT CAUSE/PROBABLE ROOT CAUSE: WELDS FAILED DUE TO UNKNOWN CAUSE, COULD BE MISUSE.