MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-17 for VITAL VUE 8886828401 manufactured by Nellcor Puritan Bennett Mexico Sa.
[142236888]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142236889]
According to the reporter, the device membrane cracked, and there is a possible contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610849-2019-00012 |
| MDR Report Key | 8522570 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | NELLCOR PURITAN BENNETT MEXICO SA |
| Manufacturer Street | BOULEVARD INSURGENTES 1903 |
| Manufacturer City | TIJUANA 22225 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22225 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE |
| Generic Name | ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD |
| Product Code | HBI |
| Date Received | 2019-04-17 |
| Model Number | 8886828401 |
| Catalog Number | 8886828401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NELLCOR PURITAN BENNETT MEXICO SA |
| Manufacturer Address | BOULEVARD INSURGENTES 1903 TIJUANA 22225 MX 22225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |