MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for VENTILATORS PNEUPAC VENTILATORS PARAPAC VENTILATOR MEDIC PARAPAC 510A1956NUS manufactured by Smiths Medical Asd,inc.
[185192549]
?investigation results completed on a smiths medical ventilator . the complaint of hearing noise for blockage and possible high pressure was not validated . when evaluation and testing was done to duplicate event, this could not be verified . as preventative measures , the flow block assembly will be replaced . unknown what was cause of event . device arrived in good condition . after preventative repairs, the device passed all testing . ?
Patient Sequence No: 1, Text Type: N, H10
[185192550]
Information received a smiths medical ventilators
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02257 |
| MDR Report Key | 9887054 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2007-05-02 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTILATORS PNEUPAC VENTILATORS PARAPAC |
| Generic Name | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
| Product Code | BTL |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-19 |
| Model Number | VENTILATOR MEDIC PARAPAC |
| Catalog Number | 510A1956NUS |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD,INC |
| Manufacturer Address | 6000 LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |