MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-19 for PNEUPAC VENTILATORS PARAPAC PLUS P310NUS manufactured by Smiths Medical Asd, Inc.
[180114677]
It was reported the device screw was stuck. This occurred while twisting the thread/stripping. In addition, when the operator tried to get the screw out as part of the preventative maintenance, they noticed that there was an issue with the screw, or pole back. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01425 |
| MDR Report Key | 9728784 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-19 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2020-02-19 |
| 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 PARAPAC PLUS |
| Generic Name | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
| Product Code | BTL |
| Date Received | 2020-02-19 |
| Model Number | P310NUS |
| Catalog Number | P310NUS |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-19 |