MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-27 for VENTILATORS PNEUPAC VENTILATORS PARAPAC PNEUPAC ACCESSORIES DH-OK50JP manufactured by Smiths Medical Asd,inc.
[185479165]
Device was returned. Supplier: (b)(4). Supplied item, dhr is at supplier.
Patient Sequence No: 1, Text Type: N, H10
[185479166]
?information received a smiths medical ventilators
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02324 |
| MDR Report Key | 9891653 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-27 |
| 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 JAPAN LTD., |
| Manufacturer Street | KOMAKI FACILITIES 627-1 YOKOUCHI, |
| Manufacturer City | KOMAKI-SHI, AICHI 485-0081 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 485-0081 |
| 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 | 2020-03-27 |
| Returned To Mfg | 2020-03-03 |
| Model Number | PNEUPAC ACCESSORIES |
| Catalog Number | DH-OK50JP |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |