MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-29 for SMITHS MEDICAL PNEUPAC DISPOSABLE CIRCUITS 100/905/302 manufactured by Smiths Medical Asd, Inc..
Report Number | 3012307300-2019-04617 |
MDR Report Key | 8946324 |
Date Received | 2019-08-29 |
Date of Report | 2019-09-24 |
Date of Event | 2019-07-31 |
Date Mfgr Received | 2019-08-05 |
Date Added to Maude | 2019-08-29 |
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 | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | DAVE HALVERSON |
Manufacturer Street | 6000 NATHAN LANE NORTH |
Manufacturer City | MINNEAPOLIS MN 55442 |
Manufacturer Country | US |
Manufacturer Postal | 55442 |
Manufacturer Phone | 7633833310 |
Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
Manufacturer Street | 6000 NATHAN LANE NORTH |
Manufacturer City | MINNEAPOLIS MN 55442 |
Manufacturer Country | US |
Manufacturer Postal Code | 55442 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | SMITHS MEDICAL PNEUPAC DISPOSABLE CIRCUITS |
Generic Name | ACCESSORY TO CONTINUOUS VENTILATOR (RESPIRATOR) |
Product Code | MOD |
Date Received | 2019-08-29 |
Catalog Number | 100/905/302 |
Lot Number | 161012 |
Device Availability | Y |
Device Age | DA |
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 55442 US 55442 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-29 |