MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-27 for NALA HARMONIC TILT PATIENT CHAIR CR433.WP1 manufactured by Herman Miller For Healthcare.
[2738282]
Neurosurgical intensive care pt sustained acute subdural hemorrhage as a result of falling from a nala harmonic tilt pt chair. Fall was unwitnessed so unclear what pt was doing immediately prior to fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026326 |
| MDR Report Key | 2679002 |
| Date Received | 2012-07-27 |
| Date of Report | 2012-07-27 |
| Date of Event | 2012-06-30 |
| Date Added to Maude | 2012-08-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NALA HARMONIC TILT PATIENT CHAIR |
| Generic Name | NALA HARMONIC TILT PATIENT CHAIR |
| Product Code | FRJ |
| Date Received | 2012-07-27 |
| Model Number | CR433.WP1 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERMAN MILLER FOR HEALTHCARE |
| Manufacturer Address | 3295 RIVER EXCHANGE DRIVE SUITE 405 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-07-27 |