MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-23 for ALGO 2EC NA NO LONGER SELL manufactured by Natus Medical, Inc..
[22076497]
The employee was unpackaging the device from the box by holding the foam siding. While removing the device the laptop slid and the employee tried to prevent the laptop from falling to the floor by holding the device by the bottom of the docking station and the employee maneuvered her fingers to better grip the docking station. In this process, her index finger caught between the consol and docking station and her fingernail split down the middle. It appeared that the device was not attached to the docking station. The employee stated that the dual-lock was not fastened correctly to the device and it would have crached to the ground if she had not caught it. The employee stated on 8/17/05 that her finger is "fine" and that she did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[22118700]
Natus will implement inspection on devices when packaging to assure that the laptop is securely fastened to the docking station.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938854-2006-00001 |
| MDR Report Key | 757767 |
| Report Source | 05 |
| Date Received | 2006-08-23 |
| Date of Report | 2006-08-04 |
| Date of Event | 2006-07-25 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2006-09-08 |
| 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 | 0 |
| Manufacturer Contact | LUANNE NG |
| Manufacturer Street | 1501 INDUSTRIAL RD |
| Manufacturer City | SAN CARLOS CA 94070 |
| Manufacturer Country | US |
| Manufacturer Postal | 94070 |
| Manufacturer Phone | 6508017306 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGO 2EC |
| Generic Name | HEARING SCREENER |
| Product Code | EWO |
| Date Received | 2006-08-23 |
| Model Number | ALGO 2EC |
| Catalog Number | NA NO LONGER SELL |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 745666 |
| Manufacturer | NATUS MEDICAL, INC. |
| Manufacturer Address | 1501 INDUSTRIAL RD. SAN CARLOS CA 94070 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-23 |