MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-01 for MAXISKY 600 AND 1000 manufactured by Arjo.
[27832335]
Arjo maxisky model 600 and 1000 have a significant downward drift when the emergency pull cord is activated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056865 |
| MDR Report Key | 5131071 |
| Date Received | 2015-10-01 |
| Date of Report | 2015-10-01 |
| Date Added to Maude | 2015-10-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAXISKY 600 AND 1000 |
| Generic Name | LIFT |
| Product Code | FNG |
| Date Received | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO |
| Manufacturer Address | US |
| Brand Name | MAXISKY 600 AND 1000 |
| Generic Name | LIFT |
| Product Code | FNG |
| Date Received | 2015-10-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ARJO |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-01 |