FDA Adverse Event
Malfunction
Summary report: N
HAMILTON-C6
MDR report key: 18128529
·
Received November 14, 2023
Report
- Report Number
- 3001421318-2023-03841
- Event Type
- Malfunction
- Date Received
- November 14, 2023
- Date of Event
- October 30, 2023
- Report Date
- August 6, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: ESMS BOARDS DEFECTIVE. CORRECTION: REPLACE ESM BOARDS.
Additional Manufacturer Narrative · 0
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: ESMS BOARDS DEFECTIVE. CORRECTION: REPLACE ESM BOARDS. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER 143636 FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D4, G3, G6, H2 AND H4.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: THE VENTILATOR DOESN'T MAKE THE BOOT AND REMAIN BLOCKED.
Description of Event or Problem · 0
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: THE VENTILATOR DOESN'T MAKE THE BOOT AND REMAIN BLOCKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1620565 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |