FDA Adverse Event
Malfunction
Summary report: N
INTELLICUFF
MDR report key: 21101947
·
Received January 8, 2025
Report
- Report Number
- 3001421318-2025-00071
- Event Type
- Malfunction
- Date Received
- January 8, 2025
- Date of Event
- October 7, 2024
- Report Date
- November 19, 2025
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- BSK
- UDI-DI
- 07630002800839
- PMA / PMN Number
- K150893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4) INITIAL REPORT.
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE CUFF PRESSURE WAS NOT MAINTAINED. ISSUE HAPPENS DURING VENTILATION, NO INTERVENTION OR PATIENT HARM REPORTED, NO LOGFILES PROVIDED. CORRECTION: INTELLICUFF REPLACED VIA RGA 100093, ISSUE SOLVED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE CUFF PRESSURE CANNOT BE MAINTAINED". THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1347745 | INTELLICUFF | INTELLICUFF PRESSURE CONTROLLER | BSK | HAMILTON MEDICAL AG | 951001 | 07630002800839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |