MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-11 for NICOLET ONE MONITOR ON ERGO CART 982A0500 NA manufactured by Natus Neurology Incorporated.
[3252634]
Panel personal computer fell off mount, hanging from cables. There was no patient or user injury, but if they were below the computer when it fell, they could have been hurt.
Patient Sequence No: 1, Text Type: D, B5
[10666451]
When product is shipped to the customer, there are several sets of screws and instructions explaining which screws to use where. The customer inserted incorrect shorter screws which caused the pc to fall. We have added clearer installation instructions starting in (b)(6) 2013 to systems shipped.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008289288-2013-00003 |
| MDR Report Key | 3060308 |
| Report Source | 05 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-03-22 |
| Date Mfgr Received | 2013-03-22 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-04-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TONI GORMAN |
| Manufacturer Street | 1850 DEMING WAY |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET ONE MONITOR ON ERGO CART |
| Generic Name | NICOLET ONE MONITOR ON ERGO CART |
| Product Code | OLV |
| Date Received | 2013-04-11 |
| Model Number | 982A0500 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Address | 1850 DEMING WAY MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-11 |