IP PTZ ERGOJUST VIDEO EXTENSIO
Report
- Report Number
- 9612330-2024-00027
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- February 6, 2024
- Report Date
- August 22, 2024
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- OMB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). IT WAS CONFIRMED THE CUSTOMER WILL NOT BE RETURNING THE CART FOR EVALUATION. ENGINEERING REVIEW STATES,"IT'S DIFFICULT TO PUSH THE CART AROUND A CORNER WHEN IT DOESN'T HAVE TWO DIRECTIONAL LOCKING CASTERS AT THE REAR. ECR#(B)(4) WAS RELEASED FOR THE IMPLEMENTATION OF TWO DIRECTIONAL LOCKING CASTERS FOR EASIER MOBILITY AROUND CORNERS. (ECO#(B)(4) ALSO GENERATED). PER (B)(4) XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET, HAZARD ID 6.6 CAUSE - ERGONOMIC DESIGN OF SYSTEM RESULTS IN REPETITIVE STRESS INJURY. EFFECTS (HARM) -RANGE FROM CLINICALLY INSIGNIFICANT TO IRREVERSIBLE INJURY RESULTING FROM DIRECT PHYSICAL INJURY RISK / BENEFIT ANALYSIS - LOW THE HAZARDS IDENTIFIED HAVE BEEN REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISK FOR THESE HAZARDS ARE CATEGORIZED AS HAVING AN RBA RATING OF LOW DUE TO THE NATURE OF THE HAZARD. HAZARDS HAVE ASSOCIATED WARNINGS DISCLOSED IN THE IFU. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. FURTHER REVIEW AND APPROVAL OF INVESTIGATION DETAILS TO BE COMPLETED BEFORE FINAL CLOSURE OF THIS CASE.
NATUS COMPLAINT# (B)(4) WAS CLOSED AUG 21, 2024. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED ECR#22803 WAS RELEASED FOR THE IMPLEMENTATION OF TWO DIRECTIONAL LOCKING CASTERS FOR EASIER MOBILITY AROUND CORNERS. (RELATED ECO#44325 WAS ALSO GENERATED).
INITIAL REPORT REF NATUS COMPLAINT# (B)(4). IT WAS STATED BY THE CUSTOMER THAT THE ISSUE IS NOT LINKED TO A SPECIFIC CART. PHOTOGRAPH OF A DEVICE WAS PROVIDED BY THE CUSTOMER, SHOWING BOX OBSTRUCTING COLLEAGUE VIEW. INSTALL DATE 17-AUG-2020. FURTHER INVESTIGATION TO BE CARRIED OUT.
IP PTZ ERGOJUST VIDEO EXTENSION - CUSTOMER STATED WITH REPETITIVE PUSHING OF CART WITH VIEW OBSTRUCTED BY MOUNTED ELECTRONIC BOX APPROXIMATELY 10.5 X 11.25 INCHES, COLLEAGUE IS FORCED TO MAINTAIN A NON-ERGONOMIC (AWKWARD & BENT/TWISTED) POSTURE WHEN PUSHING CART TO SEE WHAT IS IN FRONT AND PREVENT FROM BUMPING INTO ANYTHING WHEN MOVING CART FROM PLACE TO PLACE. ERGONOMIC EVALUATION COMPLETED BY THE CUSTOMER ON (B)(6) 2024, SUPPORTING THAT COLLEAGUE INJURY IS RELATED TO CART LAYOUT. RESTRICTIONS AND PHYSICAL THERAPY WAS RECOMMENDED. (B)(4) CARTS IDENTIFIED. DOCUMENTING CART 3/4.
IP PTZ ERGOJUST VIDEO EXTENSION - CUSTOMER STATED WITH REPETITIVE PUSHING OF CART WITH VIEW OBSTRUCTED BY MOUNTED ELECTRONIC BOX APPROXIMATELY 10.5 X 11.25 INCHES, COLLEAGUE IS FORCED TO MAINTAIN A NON-ERGONOMIC (AWKWARD & BENT/TWISTED) POSTURE WHEN PUSHING CART TO SEE WHAT IS IN FRONT AND PREVENT FROM BUMPING INTO ANYTHING WHEN MOVING CART FROM PLACE TO PLACE. ERGONOMIC EVALUATION COMPLETED BY THE CUSTOMER ON 02/12/2024, SUPPORTING THAT COLLEAGUE INJURY IS RELATED TO CART LAYOUT. RESTRICTIONS AND PHYSICAL THERAPY WAS RECOMMENDED. 4 CARTS IDENTIFIED. DOCUMENTING CART 3/4.
IP PTZ ERGOJUST VIDEO EXTENSION - CUSTOMER STATED WITH REPETITIVE PUSHING OF CART WITH VIEW OBSTRUCTED BY MOUNTED ELECTRONIC BOX APPROXIMATELY 10.5 X 11.25 INCHES, COLLEAGUE IS FORCED TO MAINTAIN A NON-ERGONOMIC (AWKWARD & BENT/TWISTED) POSTURE WHEN PUSHING CART TO SEE WHAT IS IN FRONT AND PREVENT FROM BUMPING INTO ANYTHING WHEN MOVING CART FROM PLACE TO PLACE. ERGONOMIC EVALUATION COMPLETED BY THE CUSTOMER ON (B)(6) 2024, SUPPORTING THAT COLLEAGUE INJURY IS RELATED TO CART LAYOUT. RESTRICTIONS AND PHYSICAL THERAPY WAS RECOMMENDED. 4 CARTS IDENTIFIED. DOCUMENTING CART 3/4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1570533 | IP PTZ ERGOJUST VIDEO EXTENSIO | IP PTZ ERGOJUST VIDEO EXTENSIO | OMB | NATUS MEDICAL INCORPORATED | IP-EC-VIDEO-EXT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Other |