N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7335781
- MDR report key
- 7335781
- Report number
- 1717344-2018-00348
- Event key
- 0
- Event type
- 3
- Date received
- 2018-03-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RAPIDVAC | APPARATUS, EXHAUST, SURGICAL | BUFFALO FILTER | FYD | SE3690 | SE3690 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-03-13 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE UNIT WOULD NOT MAKE A NOISE WHEN PENCIL WAS ACTIVATED. THE PATIENT INCURRED A MINOR BURN ON INNER THIGHS. THERE WAS NO MEDICAL INTERVENTION NEEDED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED AS A SERVICE REQUEST AND A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED BY THE SUPPLIER. A DEVICE HISTORY REVIEW WAS COMPLETED FOR SERIAL# (B)(4) OF WHICH WAS PRODUCED ON JUNE 2, 2016. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT FOR THIS SERIAL NUMBER. INSPECTION OF THE DEVICE RESULTED IN NOTING THAT THE RETURNED UNIT REQUIRED REPLACEMENT OF THE INSULATION COMPONENTS. THE DEVICE FAILED THE PERFORMANCE TEST. THIS COMPLAINT WILL BE CONSIDERED AS CONFIRMED. THE EXACT ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED; HOWEVER THESE ITEMS ARE SUBJECT TO WEAR AND TEAR WITH USE. AS PART OF CONTINUOUS IMPROVEMENT EFFORTS AND A CORRECTIVE ACTION, THE SUPPLIER REPAIRED AND RETURNED THE UNIT. IF ADDITIONAL INFORMATION IS RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.