REFURBISHED WIRED SECURITY CAMERA - (NV1)
Report
- Report Number
- 9612330-2023-00034
- Event Type
- Malfunction
- Date Received
- September 28, 2023
- Date of Event
- September 22, 2023
- Report Date
- April 10, 2024
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- FWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 003 REF NATUS COMPLAINT# (B)(4). RISK REVIEW: PER (B)(4) REV C RISK ANALYSIS FOR NICVIEW (CAM-001/2, ARM-001/2 CONFIGURATION), HAZARD ID - B1 POTENTIAL HAZARD - SUPPORT FAILURE. HARM - PATIENT INJURY. MITIGATION - DESIGN - SUPPORT MOUNT CAN BEAR 3X WEIGHT OF UNIT. RATING - LOW. THE CUSTOMER RETURNED ARM-002 INSTEAD OF ARM-004 AND NO BRACKET. THE INVESTIGATION WAS NOT CARRIED OUT, SINCE THE ISSUE IS WITH ARM-004. TECHNICAL SERVICE EMAILED A REQUEST FOR THE CUSTOMER TO RETURN THE CORRECT PART. (B)(6) 2024 THE CUSTOMER CONFIRMED THAT THE CAMERA WAS USED FOR AN INFANT PATIENT IN THE NICU. THE BABY WAS REMOVED FROM THE BED SO IT WOULDN'T BE DIRECTLY UNDER THE CAMERA. (B)(6) 2024 IT HAS BEEN MORE THAN 45 DAYS SINCE TECHNICAL SERVICE REQUESTED DEVICE RETURN. THE PART HAS NOT BEEN RECEIVED BACK. IF THE DEVICE IS RETURNED AT A LATER DATE, SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER QMS-004442.
INITIAL REPORT REF NATUS COMPLAINT# (B)(4). ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT PER HAZARD ID LINE B3 IN (B)(4). RISK ANALYSIS FOR NICVIEW SPREADSHEET, THE RISK IS CONSIDERED LOW. A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.
FOLLOW UPL REPORT 001 REF NATUS COMPLAINT# (B)(4). UDI#: NOT APPLICABLE THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. INSTALL DATE: (B)(6) 2023 FURTHER INVESTIGATION TO BE CARRIED OUT.
FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). NOV-09-2023 THE CUSTOMER WAS REQUESTED TO RETURN THE DEFECTIVE PART. DEC-18-2023 TECHNICAL SERVICE WAS REQUESTED TO FOLLOW UP AGIN FOR THE RETURN OF THE DEFECTIVE PART. FURTHER INVESTIGATION TO BE CARRIED OUT.
THE NICVIEW CAMERA IS HANGING ON THE ARM AND IS UNABLE TO BE APPROPRIATELY REPOSITIONED. THE CUSTOMER POINTED OUT THAT THE METAL BRACKET CONNECTING THE CAMERA TO THE ARM BROKE. THE PATIENT WAS OUT OF THE BED. NO INJURIES REPORTED.
THE NICVIEW CAMERA IS HANGING ON THE ARM AND IS UNABLE TO BE APPROPRIATELY REPOSITIONED. THE CUSTOMER POINTED OUT THAT THE METAL BRACKET CONNECTING THE CAMERA TO THE ARM BROKE. THE PATIENT WAS OUT OF THE BED. NO INJURIES REPORTED.
THE NICVIEW CAMERA IS HANGING ON THE ARM AND IS UNABLE TO BE APPROPRIATELY REPOSITIONED. THE CUSTOMER POINTED OUT THAT THE METAL BRACKET CONNECTING THE CAMERA TO THE ARM BROKE. THE PATIENT WAS OUT OF THE BED. NO INJURIES REPORTED.
THE NICVIEW CAMERA IS HANGING ON THE ARM AND IS UNABLE TO BE APPROPRIATELY REPOSITIONED. THE CUSTOMER POINTED OUT THAT THE METAL BRACKET CONNECTING THE CAMERA TO THE ARM BROKE. THE PATIENT WAS OUT OF THE BED. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1976926 | REFURBISHED WIRED SECURITY CAMERA - (NV1) | REFURBISHED WIRED SECURITY CAMERA - (NV1) | FWC | NATUS MEDICAL INCORPORATED | CAM-002R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |