HAMILTON-C6
Report
- Report Number
- 3001421318-2024-00144
- Event Type
- Death
- Date Received
- January 17, 2024
- Date of Event
- January 12, 2024
- Report Date
- October 11, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- 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: INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
ON JUL 2, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GEL MOD-RND 300CC BREAST IMPLANT WAS FOUND TO BE RUPTURED AND RECEIVED IN (3) THREE PARTS. IN ADDITION, SHELL ABRASION WAS NOTED ON THE EDGES OF THE RUPTURE. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE WAS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGESTS IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE FOLLOWING FACTORS: CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE SUCH AS TOO SMALL BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. IN SOME CASES, THE BREAST IMPLANTS MAY ALSO WEAR OUT OVER TIME. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: INVESSTIGATION ONGOING.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: AFTER MIDNIGHT ON JANUARY 12, THE SCREEN OF THE HAMILTON-C6 WENT BLACK, SO THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR, BUT A PATIENT PASSED AWAY AT AROUND 1:15. THE SITUATION AT THE TIME OF THE INCIDENT WAS THAT THE PATIENT WAS BEING CARED FOR AT THE END OF HIS LIFE, SO HIS FAMILY WAS WITH THE PATIENT, AND THE FAMILY CONTACTED THE NURSE ABOUT THE BLACKOUT PHENOMENON, THEN THE NURSE CONTACTED THE CE TO DISCUSS HOW TO DEAL WITH IT. THE CE WAS NOT AT THE HOSPITAL, SO A DOCTOR AND THE NURSE REPLACED THE C6 WITH ANOTHER VENTILATOR. AFTER THAT, DURING THE DAYTIME SHIFT, THE CE TRIED TO TURN OFF THE DEVICE, BUT IT WOULDN'T TURN OFF. HE COULD RESTART IT BY TURNING THE MAIN SWITCH ON AND OFF SEVERAL TIMES, BUT WHEN IT STARTED UP, THE STATUS BAR OF LOADING STOPPED AT ABOUT 80% AND SCREEN WAS FROZEN. AT AROUND 11 A.M. , OUR BRANCH STAFF VISITED THE SITE TO CHECK THE SITUATION AND STARTED UP THE SYSTEM, THEN IT STARTED IT UP PROPERLY AND THEY COULD EXPORT LOG FILES.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: AFTER MIDNIGHT ON JANUARY 12, THE SCREEN OF THE HAMILTON-C6 WENT BLACK, SO THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR, BUT A PATIENT PASSED AWAY AT AROUND 1:15. THE SITUATION AT THE TIME OF THE INCIDENT WAS THAT THE PATIENT WAS BEING CARED FOR AT THE END OF HIS LIFE, SO HIS FAMILY WAS WITH THE PATIENT, AND THE FAMILY CONTACTED THE NURSE ABOUT THE BLACKOUT PHENOMENON, THEN THE NURSE CONTACTED THE CE TO DISCUSS HOW TO DEAL WITH IT. THE CE WAS NOT AT THE HOSPITAL, SO A DOCTOR AND THE NURSE REPLACED THE C6 WITH ANOTHER VENTILATOR. AFTER THAT, DURING THE DAYTIME SHIFT, THE CE TRIED TO TURN OFF THE DEVICE, BUT IT WOULDN'T TURN OFF. HE COULD RESTART IT BY TURNING THE MAIN SWITCH ON AND OFF SEVERAL TIMES, BUT WHEN IT STARTED UP, THE STATUS BAR OF LOADING STOPPED AT ABOUT 80% AND SCREEN WAS FROZEN. AT AROUND 11 A.M. , OUR BRANCH STAFF VISITED THE SITE TO CHECK THE SITUATION AND STARTED UP THE SYSTEM, THEN IT STARTED IT UP PROPERLY AND THEY COULD EXPORT LOG FILES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395546 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| D |