N
Patient 1
(B)(4).
MAUDE MDR 8446681
- MDR report key
- 8446681
- Report number
- 8040412-2019-00077
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-03-08
- Date received
- 2019-03-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KATHARINE TARPLEY
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HUDSON BACTERIAL/VIRAL FILTER | FILTER, BACTERIAL, BREATHING-C | TELEFLEX MEDICAL | CAH | 1605 | 201826 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-24 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER COMPLAINT ALLEGES "THERE MUST BE A LEAK IN THE FILTERS BECAUSE OUR VENTILATORS WOULD NOT PASS THE LEAK TEST WITH THE INSPIRATORY FILTER INLINE, BUT WOULD PASS WITHOUT". ALLEGED ISSUE REPORTED DETECTED DURING FUNCTIONAL TESTING OF THE VENTILATOR SET UP PRIOR TO A PATIENT USE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED.