MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-03 for PNEUPAC? PARAPAC? VENTILATOR 120003 manufactured by Smiths Medical Asd; Inc..
[181835562]
Information was received indicating that a smiths medical pneupac? Parapac? Ventilator stopped working when the patient was in magnetic resonance imaging (mri). It was reported that the alarm did not sound "low pressure alarm" at the time it stopped. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01647 |
| MDR Report Key | 9782177 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2007-08-31 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Returned To Mfg | 2020-02-06 |
| Model Number | 120003 |
| Catalog Number | 120003 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-03 |