D
Patient 1
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC PARAPAC VENTILATOR IS NOT OPERATING CORRECTLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
MAUDE MDR 9863648
- MDR report key
- 9863648
- Report number
- 3012307300-2020-02084
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-22
- 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
- DAVE HALVERSON
- Address
- 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PNEUPAC PARAPAC VENTILATOR | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) PRODUCT CODE: BTL | SMITHS MEDICAL ASD, INC. | BTL | 120003? | 120003? | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-22 | 0 |