OLM INTRACRANIAL PRESSURE MONITORING KIT
Report
- Report Number
- 2023988-2023-00041
- Event Type
- Malfunction
- Date Received
- November 10, 2023
- Date of Event
- October 23, 2023
- Report Date
- July 19, 2024
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- GWM
- UDI-DI
- 00382830047494
- PMA / PMN Number
- K102875
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORT REF NATUS COMPLAINT# (B)(4). ACCEPTABLE RISK AS PER HAZARD ID 12.1, SEVERITY 0, IN DOC-047178 CAMINO 110-4 SERIES CATHETER KITS-RISK ANALYSIS. RISK IS CONSIDERED TO BE LOW. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. FURTHER INVESTIGATION TO BE CARRIED OUT.
FOLLOW UP REPORT 001 NATUS COMPLAINT# (B)(4). THREE ATTEMPTS WERE MADE TO CONFIRM IF THE AFFECTED PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION ON NOVEMBER 8TH, 15TH AND 22ND, 2023. 28-NOV-2023: COMPLETED COMPLAINT FORM RETURNED, CONFIRMED PART WAS AVAILABLE TO BE RETURNED. CUSTOMER WAS SENT ANOTHER THREE REMINDERS TO RETURN THE PRODUCT ON DECEMBER 14TH, 24TH AND 29TH, 2023. DEVICE WAS NOT RETURNED FOR EVALUATION. INVOICE SENT JANUARY 14TH, 2024. NO DEVICE HISTORY RECORD REVIEW CARRIED OUT FOR THIS PRODUCT. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 1 CONFIRMED COMPLAINT, GIVING A FAILURE RATE OF (B)(4)%. FURTHER INVESTIGATION TO BE CARRIED OUT BEFORE FINAL CLOSURE OF COMPLAINT CASE.
FOLLOW UP REPORT 002 NATUS COMPLAINT# (B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED, THE RAW MATERIALS USED IN THE MANUFACTURING MET SPECIFICATIONS AND THERE WERE NO ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING, OR INSPECTION OF THE DEVICE IN PROCESS. NO ASSOCIATED CAPAS. ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ANY FURTHER INFORMATION REGARDING THE INCIDENT. THE DEVICE HISTORY RECORDS SHOW THE CATHETER MET SPECIFICATIONS PRIOR TO RELEASE. FAILURE MODE: UNCONFIRMED/ NO DEVICE RETURNED.
PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - DURING DOCTOR'S ROBOTIC SEEG (STEREOELECTROENCEPHALOGRAPHY) CASE, HE WANTED TO USE A NATUS CAMINO INTRACRANIAL PRESSURE MONITOR. WHEN HE WENT TO ZERO IT OUT BEFORE USE, IT REMAINED AT A SETTING OF 300 AND WOULD NOT MOVE. HE USED A DIFFERENT ONE INSTEAD. NO INJURIES REPORTED.
PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - DURING DOCTOR'S ROBOTIC SEEG (STEREOELECTROENCEPHALOGRAPHY) CASE, HE WANTED TO USE A NATUS CAMINO INTRACRANIAL PRESSURE MONITOR. WHEN HE WENT TO ZERO IT OUT BEFORE USE, IT REMAINED AT A SETTING OF 300 AND WOULD NOT MOVE. HE USED A DIFFERENT ONE INSTEAD. NO INJURIES REPORTED.
PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - DURING DOCTOR'S ROBOTIC SEEG (STEREOELECTROENCEPHALOGRAPHY) CASE, HE WANTED TO USE A NATUS CAMINO INTRACRANIAL PRESSURE MONITOR. WHEN HE WENT TO ZERO IT OUT BEFORE USE, IT REMAINED AT A SETTING OF 300 AND WOULD NOT MOVE. HE USED A DIFFERENT ONE INSTEAD. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1866985 | OLM INTRACRANIAL PRESSURE MONITORING KIT | OLM INTRACRANIAL PRESSURE MONITORING KIT | GWM | NATUS MEDICAL INCORPORATED | 1104B | 118D00960448 | 00382830047494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Female |