INTELLICUFF
Report
- Report Number
- 3001421318-2024-00681
- Event Type
- Malfunction
- Date Received
- March 21, 2024
- Date of Event
- February 12, 2024
- Report Date
- February 7, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- BSK
- UDI-DI
- 07630002800839
- PMA / PMN Number
- K150893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION IS ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION IS ONGOING.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION IS ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE HOSPITAL STAFF REPORTED THAT THE CUFF CONNECTOR WAS BROKEN. THE APPLIED PRESSURE COULD NOT INFLATE THE BALLOON. IF A LEAKAGE OF THE SYSTEM (INTELLICUFF AND CUFF PRESSURE TUBE FOR INTELLICUFF) LEADS TO A FAILURE TO ACHIEVE AND MAINTAIN THE CHOSEN PRESSURE LEVEL, THE DEVICE BECOMES INOPERABLE AND DOES NOT WORK AS INTENDED. THE ROOT CAUSE WAS ATTRIBUTED TO A VISIBLE CRACK IN THE CONNECTOR OF THE INTELLICUFF PNEUMATIC CUFF. IN THIS CASE THERE WAS NO PATIENT INVOLVEMENT BUT IF SUCH AN INCIDENT OCCURRED DURING VENTILATION A DETERIORATION OF THE PATIENT'S HEALTH CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS ASSESSED REPORTABLE.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS THE CUFF PRESSURE TUBE CONNECTOR, WHICH IS LOCATED AT THE BOTTOM OF THE INTELLICUFF HANDHELD HOUSING, HAS BEEN BROKEN OFF. WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. NO FURTHER DETAILS ABOUT WHEN AND HOW THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS THE CUFF PRESSURE TUBE CONNECTOR, WHICH IS LOCATED AT THE BOTTOM OF THE INTELLICUFF HANDHELD HOUSING, HAS BEEN BROKEN OFF. WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. NO FURTHER DETAILS ABOUT WHEN AND HOW THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS THE CUFF PRESSURE TUBE CONNECTOR, WHICH IS LOCATED AT THE BOTTOM OF THE INTELLICUFF HANDHELD HOUSING, HAS BEEN BROKEN OFF. - WHEN THIS WAS NOTICED, THE VENTILATOR WAS NOT IN USE TO VENTILATE A PATIENT. NO FURTHER DETAILS ABOUT WHEN AND HOW THIS HAPPENED WERE REPORTED TO HAMILTON MEDICAL AG. - WHETHER ALARMS WERE TRIGGERED WAS NOT REPORTED. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1755167 | INTELLICUFF | INTELLICUFF PRESSURE CONTROLLER | BSK | HAMILTON MEDICAL AG | 951001 | 07630002800839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |