MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for STRYKER NEPTUNE ROVER 0702-001-000 manufactured by Stryker Instruments.
[127609759]
Stryker neptune rover that was docked for cleaning / disinfection, experienced a water leak at the docking station and could not be released for removal from the docking station. The rover unit then commenced to short circuit and cause an internal electrical fire in the rover unit. Fire alarm pulled with fire company response to assist with remediation of the indicated issue.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5081446 |
MDR Report Key | 8085468 |
Date Received | 2018-11-19 |
Date of Report | 2018-11-16 |
Date of Event | 2018-11-15 |
Date Added to Maude | 2018-11-19 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
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 | 3 |
Brand Name | STRYKER NEPTUNE ROVER |
Generic Name | APPARATUS, EXHAUST, SURGICAL |
Product Code | FYD |
Date Received | 2018-11-19 |
Model Number | 0702-001-000 |
Catalog Number | 0702-001-000 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 0 |
Device Event Key | 0 |
Manufacturer | STRYKER INSTRUMENTS |
Manufacturer Address | KALAMAZOO CA 49002 US 49002 |
Brand Name | STRYKER NEPTUNE ROVER |
Generic Name | APPARATUS, EXHAUST, SURGICAL |
Product Code | FYD |
Date Received | 2018-11-19 |
Model Number | 0702-001-000 |
Catalog Number | 0702-001-000 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER CORPORATION (SURGICAL DIVISION) |
Manufacturer Address | KALAMAZOO CA 49002 US 49002 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-11-19 |