MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-09 for VITAL VUE* LIGHT POWER SOURCE (110V) 8886828401 manufactured by Covidien, Formerly Nellcor Puritan Benne.
[19434488]
According to the reporter: device was broken.
Patient Sequence No: 1, Text Type: D, B5
[19522679]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610849-2015-00001 |
| MDR Report Key | 4902278 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-25 |
| Date Mfgr Received | 2015-06-25 |
| Date Added to Maude | 2015-08-03 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY NELLCOR PURITAN BENNE |
| Manufacturer Street | BLVD. INSURGENTES 19030 LIBRIAMENTO |
| Manufacturer City | TIJUANA, B.C. |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE* LIGHT POWER SOURCE (110V) |
| Generic Name | SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS |
| Product Code | HBI |
| Date Received | 2015-07-09 |
| Returned To Mfg | 2015-06-30 |
| Model Number | 8886828401 |
| Catalog Number | 8886828401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY NELLCOR PURITAN BENNE |
| Manufacturer Address | BLVD. INSURGENTES 19030 LIBRIAMENTO TIJUANA, B.C. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-09 |