MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for PNEUPAC VENTILATORS VENTIPAC V200DNUS 130003V manufactured by Smiths Medical Asd, Inc.
[181454886]
Device evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10
[181454887]
It was reported the device was dropped and had a broken battery door. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01595 |
| MDR Report Key | 9771679 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2005-10-05 |
| Date Added to Maude | 2020-02-28 |
| 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 NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL, INTERNATIONAL LTD. |
| Manufacturer Street | BRAMINGHAM BUSINESS PARK, ENTERPRISE WAY, |
| Manufacturer City | LUTON, BEDS |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUPAC VENTILATORS VENTIPAC |
| Generic Name | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
| Product Code | BTL |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-04 |
| Model Number | V200DNUS |
| Catalog Number | 130003V |
| 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 NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |