MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-31 for A SERIES * 5221EU manufactured by Vital Signs, Inc.
[15177742]
A large portion, over 20, of the infant face masks in our omnicell was deflated. They were unable to be put into use due to poor seal on face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3605124 |
| MDR Report Key | 3605124 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-31 |
| Date of Event | 2014-01-03 |
| Report Date | 2014-01-31 |
| Date Reported to FDA | 2014-01-31 |
| Date Reported to Mfgr | 2014-02-04 |
| Date Added to Maude | 2014-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A SERIES |
| Generic Name | MASK, GAS |
| Product Code | BSJ |
| Date Received | 2014-01-31 |
| Model Number | * |
| Catalog Number | 5221EU |
| Lot Number | 12333B |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL SIGNS, INC |
| Manufacturer Address | 20 CAMPUS RD TOTOWA NJ 07512 US 07512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-31 |