MOBILE CART CAMERA
Received Mar 9, 2020
Report 9612330-2020-00003 · MDR key 9805143
Device
Product problems
- Device Damaged Prior to Use
- Defective Device
- Device Damaged Prior to Use
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- Not Applicable
- No Known Impact Or Consequence To Patient
- Not Applicable
Narrative
Description of Event or Problem
MOBILE CART CAMERA FELL ON THE EEG TECHNICIAN HEAD.
Additional Manufacturer Narrative
UPDATE 07TH MAY 2020: INVESTIGATION RESULTS & FINDINGS (NATUS COMPLAINT REF. # 1-702493582). RISK REVIEW: PER DOC-010378 - EEG/PSG RISK ANALYSIS, HAZARD ID - 6.4 IDENTIFIES "SYSTEM CART OR PERIPHERALS FALL OR TIP ONTO PATIENT OR USER WHEN CART IS IDLE, IN MOTION, OR DURING ATTEMPT TO TRAVERSE A THRESHOLD OR OBSTACLE." THE RISK IS CONSIDERED MODERATE. UPON EVALUATION OF THE UNIT, IT WAS NOTED THAT THE MOUNTING TREAD ON BOTH SIDES OF THE CAMERA ARE COMPLETELY DESTROYED WHICH WOULD HAVE BEEN CAUSED BY MISALIGNING THE CAMERA AND POLE WHEN THE CAMERA WAS MOUNTED. THE DESTRUCTION OF THE BOTTOM TREAD SUGGESTS THAT AN ATTEMPT WAS MADE TO MOUNT IT ON THE POLE. THE LACK OF A SECURE, RIDGED ASSEMBLY BETWEEN THE CAMERA AND CARTS POLE COULD RESULT IN THE CAMERA FALLING OFF THE CART. A REPLACEMENT UNIT HAS BEEN SENT TO THE CUSTOMER. THE COMPLAINT AS REPORTED WAS VERIFIED. THIS HAS BEEN DEEMED AN ISOLATED INCIDENT AND WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCE.
Description of Event or Problem
MOBILE CART CAMERA FELL ON THE EEG TECHNICIAN HEAD.
Additional Manufacturer Narrative
UPDATE 09TH APRIL 2020 MANUFACTURERS INTERNAL REPORT REF. # (B)(4). INVESTIGATION RESULTS & FINDINGS THE SUSPECT DEVICE HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION IS IN PROGRESS.
Additional Manufacturer Narrative
MOBILE CART CAMERA HAS FALLEN ON THE EEG TECHNICIAN HEAD.
Description of Event or Problem
MOBILE CART CAMERA FELL ON THE EEG TECHNICIAN HEAD.