HAMILTON-C3
Report
- Report Number
- 3001421318-2024-01153
- Event Type
- Injury
- Date Received
- May 14, 2024
- Date of Event
- May 8, 2024
- Report Date
- November 14, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002801881
- PMA / PMN Number
- K201306
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: BLOWER DEFECTIVE. CORRECTION: REPLACED DEFECTIVE COMPONENT.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: BLOWER DEFECTIVE. CORRECTION: REPLACED DEFECTIVE COMPONENT.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: BLOWER MODULE DEFECTIVE. CORRECTION: REPLACED DEFECTIVE COMPONENT.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: BLOWER MODULE DEFECTIVE. CORRECTION: REPLACED DEFECTIVE COMPONENT. ADDITIONAL INFORMATION: H4, H6. CORRECTED INFORMATION: B1, D4, H6, B11. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 3 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION, UPDATED FIELDS: B4, D1, D2A, D4, D8, G1, G2, G6, H2, H4, H5.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TE231009 OCCURRED AND THE DEVICE DIDN'T VENTILATE AS SETTINGS. SPO2 DECREASED TEMPORALLY, BUT IT WAS RECOVERED BY MANUAL VENTILATION AND THE VENTILATOR REPLACEMENT.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TE231009 OCCURRED AND THE DEVICE DIDN'T VENTILATE AS SETTINGS. SPO2 DECREASED TEMPORALLY, BUT IT WAS RECOVERED BY MANUAL VENTILATION AND THE VENTILATOR REPLACEMENT.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: (B)(6) OCCURRED AND THE DEVICE DIDN'T VENTILATE AS SETTINGS. SPO2 DECREASED TEMPORALLY, BUT IT WAS RECOVERED BY MANUAL VENTILATION AND THE VENTILATOR REPLACEMENT.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TE231009 OCCURRED AND THE DEVICE DIDN'T VENTILATE AS SETTINGS. SPO2 DECREASED TEMPORALLY, BUT IT WAS RECOVERED BY MANUAL VENTILATION AND THE VENTILATOR REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488679 | HAMILTON-C3 | HAMILTON-C3 | CBK | HAMILTON MEDICAL AG | 160005 | 07630002801881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |