MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-04 for PNEUPAC? PARAPAC? VENTILATOR 120003 manufactured by Smiths Medical Asd; Inc..
[182132206]
Information was received indicating that a smiths medical pneupac? Parapac? Ventilator was missing knobs. It was reported that the pressure pop-off was set to 40cm h2o. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01809 |
| MDR Report Key | 9788660 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2014-09-16 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Street | BRAMINGHAM BUSINESS PARK ENTERPRISE WAY |
| Manufacturer City | LUTON, BEDS LU3 4BU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LU3 4BU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUPAC? PARAPAC? VENTILATOR |
| Generic Name | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
| Product Code | BTL |
| Date Received | 2020-03-04 |
| Model Number | 120003 |
| Catalog Number | 120003 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |