MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-11-23 for VENOSCOPE II NEONATAL TRANSILLUMINATOR NT01 manufactured by Venoscope, Llc.
[20002874]
Infant needed iv started. Venoscope ii neonatal transilluminator used to aid site selection. Transilluminator off for most of the time during site selection. Nurse checked temperature of light on transilluminator several times; light not hot. However, light was held in place for 2 minutes during procedure. After task completed, an open and slightly weeping area noted in forearm with scant serous fluid and mild edema.
Patient Sequence No: 1, Text Type: D, B5
[20275923]
(b)(6). During assembly two wires on the pc board to the led lights were reversed. Although the light passed the quality check we discovered that it would accumulate heat that was out of spec for the device. We replaced all of the lights in the affected batch. We replaced the user facilities device and, upon investigation, we discovered that they returned the wrong device. That is why the subject light was brighter than the other 2 lights that they have.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2319429-2005-00001 |
| MDR Report Key | 2737454 |
| Report Source | 06 |
| Date Received | 2005-11-23 |
| Date of Report | 2005-11-10 |
| Date of Event | 2005-11-02 |
| Date Facility Aware | 2005-11-02 |
| Report Date | 2005-11-10 |
| Date Reported to FDA | 2005-11-10 |
| Date Reported to Mfgr | 2005-11-10 |
| Date Mfgr Received | 2005-11-02 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2012-09-12 |
| 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 | FRANK CREAGHAN |
| Manufacturer Street | 200 TRAVIS STREET SUITE 101 |
| Manufacturer City | LAFAYETTE LA 70503 |
| Manufacturer Country | US |
| Manufacturer Postal | 70503 |
| Manufacturer Phone | 3372348993 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENOSCOPE II NEONATAL TRANSILLUMINATOR |
| Generic Name | NEONATAL TRANSILLUMINATOR |
| Product Code | HJN |
| Date Received | 2005-11-23 |
| Model Number | NT01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENOSCOPE, LLC |
| Manufacturer Address | 1018 HARDING ST., SUITE 104 LAFAYETTE LA 70503 US 70503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-23 |