MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-22 for SKYTRON manufactured by .
[3134671]
During hour 4 of an open abdominal surgery, the bed experienced a failure of hydrostatic pressure and rapid leak of hydraulic fluid. The head of the bed lower rapidly into trendelenburg position. Due to the phase of the surgery at that time, the pt was not harmed. The pt was redraped to address any breaches in sterility and a stool was used to stabilize the head of the bed and return it to a horizontal plane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029144 |
| MDR Report Key | 2982684 |
| Date Received | 2013-02-22 |
| Date of Report | 2013-02-22 |
| Date of Event | 2013-01-16 |
| Date Added to Maude | 2013-03-01 |
| 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 |
| 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 | SKYTRON |
| Generic Name | HERCULES BED O.R BED |
| Product Code | LGX |
| Date Received | 2013-02-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-22 |