MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-15 for VIVAX MOBILITY SYSTEM (NOVA BED) * manufactured by Vivax Medical Corp..
[77610]
Pt self extubated. Unable to flatten specialty bed during code. Specialty bed is dependent upon multiple tasks and computer instructions being performed sequentially. Sensors and multiple mechanisms must be operational and within adjustment parameters to allow specific functions to take place. Manual override features are not readily accessible should manual operation be required. A cpr release tag flattened the air mattress portion of the bed but did not flatten the bed which is the standard on other critical care specialty beds (a cpr lever or cord lowers both head and leg sections to allow pt to lie flat). Pt had to be moved to another bed for resuscitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002054 |
| MDR Report Key | 144609 |
| Date Received | 1998-01-15 |
| Date of Report | 1997-12-22 |
| Date of Event | 1997-11-07 |
| Date Added to Maude | 1998-01-21 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVAX MOBILITY SYSTEM (NOVA BED) |
| Generic Name | SPECIALTY BED/CHAIR FOR OVERSIZED PATIENTS |
| Product Code | FRZ |
| Date Received | 1998-01-15 |
| Returned To Mfg | 1997-11-17 |
| Model Number | NOVA BED |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 140996 |
| Manufacturer | VIVAX MEDICAL CORP. |
| Manufacturer Address | 545 MIDDLE ST. BRISTOL CT 06010 US |
| Baseline Brand Name | VIVAX MOBILITY SYSTEM |
| Baseline Generic Name | PATIENT TRANSFER SYSTEM |
| Baseline Model No | NOVA BED |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | VIVAX MOBILITY SYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K964246 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1998-01-15 |