MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-05-22 for GREENLIGHT II 4558GSP manufactured by Vital Signs Colorado, Inc..
[1129558]
Account reported that the light would not stay on, it was intermittent and then light would go off. They tried 3 different blades with the handle and all reacted the same way. Upon review of the handle by the account, they felt the batteries were loose in the cartridge and were not touching with the metal contact. The batteries can be removed just by tilting the cartridge in any direction.
Patient Sequence No: 1, Text Type: D, B5
[8328552]
Thirteen samples returned for evaluation. The reported problem was verified in each of the samples. Each sample was examined under magnification, with no damage seen on the battery clips. The returned samples were tested for material thickness and compared to 15 samples from current inventory, all were found to be within spec. Battery clips from inventory were used to determine the force required to bend the clips to the height of the returned samples. Two battery clips from inventory were measured and found to be of correct height. In order to bend to clip to the height of the returned samples, a force of 65-105 lbs was required. According to the customer, the handles are stored in "tech" boxes in the ambulance and in different positions depending on the clinician or ambulance design. This device is to be used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management. The handle consists of a led light powered by 2 aa batteries and a head that incorporates a hook-on fitting that connects a detachable fiber-illuminated blade. The led module incorporates an electrical contact so that when the blade is engaged to the hook-on fitting and in the operating position, the led illuminates. This device is to be tested prior to use, per the instructions for use. It should not be used if it is not operating properly and therefore, the pt would not suffer any serious injury or death. The force required to bend to battery clips in "normal" use cannot be explained. The cause of the reported defect cannot be determined. We will continue to monitor this defect for future trend analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718887-2009-00001 |
| MDR Report Key | 1394187 |
| Report Source | 05,07 |
| Date Received | 2009-05-22 |
| Date of Report | 2009-05-22 |
| Date of Event | 2009-03-26 |
| Date Mfgr Received | 2009-03-30 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2009-06-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 11039 EAST LANSING CIR. |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 8007901330 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENLIGHT II |
| Generic Name | GREEN STANDAR LARYNGOSCOPE HANDLE |
| Product Code | EQN |
| Date Received | 2009-05-22 |
| Returned To Mfg | 2009-03-30 |
| Model Number | NA |
| Catalog Number | 4558GSP |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL SIGNS COLORADO, INC. |
| Manufacturer Address | 11039 EAST LANSING CIR. ENGLEWOOD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-05-22 |