INTELLICUFF
Report
- Report Number
- 3001421318-2024-00110
- Event Type
- Malfunction
- Date Received
- January 13, 2024
- Date of Event
- December 7, 2023
- Report Date
- October 11, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- BSK
- UDI-DI
- 07630002800839
- PMA / PMN Number
- K150893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4) . INVESTIGATION IS ONGOING. CORRECTIONS MADE IN FOLLOW UP 1: B5 > THE ASSESSMENT HAS BEEN ADJUSTED BASED ON NEW INPUT AND THE REFLEXION WHAT IS MADE. D4 > PART NUMBER IS EXCHANGED FROM PN 951001 (INTELLICUFF, STANDALONE) INTO PN 160784 (INTELLICUFF KIT). THE INTELLICUFF KIT PN 160784 INCLUDES AN INTELLICUFF CONTROLLER PN 951001, CUFF TUBING SHORT, AND MOUNTING.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION IS ONGOING.
HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION IS ONGOING. CORRECTIONS MADE IN FOLLOW UP 1: - B5 > THE ASSESSMENT HAS BEEN ADJUSTED BASED ON NEW INPUT AND THE REFLEXION WHAT IS MADE. - D4 > PART NUMBER IS EXCHANGED FROM PN 951001 (INTELLICUFF, STANDALONE) INTO PN 160784 (INTELLICUFF KIT). THE INTELLICUFF KIT PN 160784 INCLUDES AN INTELLICUFF CONTROLLER PN 951001, CUFF TUBING SHORT, AND MOUNTING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. THE PART NUMBER WAS REVERTED TO 951001 (CONFORMING TO GUDID DATABASE INFORMATION). UPDATED FIELDS: B4, D4, G6, H2, H4, H11.
THE ASSESSMENT HAS BEEN ADJUSTED BASED ON NEW INPUT AND THE REFLEXION WHAT IS MADE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE. RATIONALE: - IT WAS REPORTED TO HAMILTON THAT THE SETUP CONSISTING OF A HAMILTON-C6 VENTILATOR DEVICE FITTED WITH AN INTEGRATED INTELLICUFF-KIT (PN 160784, SN (B)(6) ) ALARMED WHEREBY A "CHECK INTELLICUFF" ERROR MESSAGES APPEARED TO THE SCREEN OF THE VENTILATOR DEVICE. IT WAS NOTICED THAT THE MOTOR WAS MALFUNCTIONING, AND THE PRESSURE COULD NOT BE ADJUSTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON AND SHOWED THAT THIS OCCURRED EARLIER. THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING PATIENT VENTILATION. THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. THE INTEGRATED INTELLICUFF-KIT (PN 160784, SN (B)(6) ) GOT EXCHANGED BY A STANDALONE INTELLICUFF (PN951001). NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. FAULT FINDING: THE FAULTY INTEGRATED INTELLICUFF-KIT (PN 160784, SN (B)(6) ) WAS TAKEN OUT OF SERVICE AND CHECKED AS STANDALONE INTELLICUFF WHAT LEADED TO A TF10 FAULT ALARM. THE INVESTIGATION IS STILL ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: WHAT PRECEDED IS THAT THE CUSTOMER WAS USING A HAMILTON-C6 VENTILATOR DEVICE WITH AN INTEGRATED INTELLICUFF-KIT (PN160784) AND REPORTED TO HAMILTON THE FOLLOWING: MOTOR DOES NOT WORK, PRESSURE CANNOT BE ADJUSTED, TF10. THIS CASE HAS BEEN REGISTER AS DURING USE, A RED CHECK INTELLICUFF ALARM APPEARS ON THE SCREEN OF THE VENTILATOR DEVICE MODEL HAMILTON-C6 AND I THEN PERFORMED AN OPERATIONAL CHECK. THEN TF10 OCCURRED. WHAT FOLLOWED IS THAT INSTEAD OF USING THE INTEGRATED INTELLICUFF-KIT (PN160784) OF THE HAMILTON-C6 VENTILATOR DEVICE, A STANDALONE INTELLICUFF (PN951001, SN (B)(6) GOT USED. THIS STANDALONE INTELLICUFF (PN951001, SN (B)(6) ALARMED AS WELL. ALL DISPLAY LIGHTS BLINKED. THE IFU OF THE STANDALONE INTELLITCUFF(PN951001) POINTS OUT THAT THIS IS A TECHNICAL FAULT, VARIOUS CAUSES ARE POSSIBLE. CONTACT HAMILTON. THERE IS NEED FOR ANY MEDICAL INTERVENTION REPORTED. THE INTEGRATED INTELLICUFF-KIT(PN160784) GOT EXCHANGED WITH A STANDALONE INTELLICUFF (PN951001, SN (B)(6) . BOTH TYPE OF INTELLICUFFS ALARMED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.
THE ASSESSMENT HAS BEEN ADJUSTED BASED ON NEW INPUT AND THE REFLEXION WHAT IS MADE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE. RATIONALE: - IT WAS REPORTED TO HAMILTON THAT THE SETUP CONSISTING OF A HAMILTON-C6 VENTILATOR DEVICE FITTED WITH AN INTEGRATED INTELLICUFF-KIT (PN 160784, SN (B)(6)) ALARMED WHEREBY A "CHECK INTELLICUFF" ERROR MESSAGES APPEARED TO THE SCREEN OF THE VENTILATOR DEVICE. IT WAS NOTICED THAT THE MOTOR WAS MALFUNCTIONING, AND THE PRESSURE COULD NOT BE ADJUSTED. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. - THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON AND SHOWED THAT THIS OCCURRED EARLIER. - THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING PATIENT VENTILATION. - THERE IS NEED FOR MEDICAL INTERVENTION REPORTED. THE INTEGRATED INTELLICUFF-KIT (PN 160784, SN (B)(6)) GOT EXCHANGED BY A STANDALONE INTELLICUFF (PN 951001). - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. - FAULT FINDING: THE FAULTY INTEGRATED INTELLICUFF-KIT (PN 160784, SN (B)(6)) WAS TAKEN OUT OF SERVICE AND CHECKED AS STANDALONE INTELLICUFF WHAT LEADED TO A TF10 FAULT ALARM. THE INVESTIGATION IS STILL ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1817697 | INTELLICUFF | INTELLICUFF PRESSURE CONTROLLER | BSK | HAMILTON MEDICAL AG | 951001 | 07630002800839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |