MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-20 for PNEUPAC? PARAPAC? VENTILATOR, 120003 manufactured by Smiths Medical Asd; Inc..
[180116065]
Information was received indicating that a smiths medical pneupac? Parapac? Ventilator reported to stop functioning while transferring a patient to magnetic resonance imaging (mri). It was noted that the vent would cycle one time and then stop operating. The breath indicator blinked with no ventilator function. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01191 |
| MDR Report Key | 9731118 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-06-01 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2011-06-14 |
| Date Added to Maude | 2020-02-20 |
| 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 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Street | BRAMINGHAM BUSINESS PARK ENTERPRISE WAY |
| Manufacturer City | LUTON, 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 | 2020-02-20 |
| 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 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |