MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-29 for PHILIPS SURGICAL TABLE 6002B 381072 manufactured by Skytron.
[15161186]
Operating room bed (skytron) allegedly malfunctioned during the administration of spinal anesthesia for a c-section, injuring the anesthesiologist. Pt placed on table & positioned in trendelenburg; the anesthesiologist turned to get something and noticed the table losing its position, so he pushed the button to get back into positon and the table lost a lot of oil then dropping the pt quickly. The physician held the bed in position so that the pt would not be injured, subsequently injuring himself (shoulder/upper-arm injury).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5014086 |
MDR Report Key | 1564884 |
Date Received | 2009-12-29 |
Date of Report | 2009-12-29 |
Date of Event | 2009-10-05 |
Date Added to Maude | 2010-01-05 |
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 | PHILIPS SURGICAL TABLE |
Generic Name | SKYTRON DIV THE KMW GROUP - ULTRASLIDE |
Product Code | FWX |
Date Received | 2009-12-29 |
Model Number | 6002B |
Catalog Number | 381072 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SKYTRON |
Manufacturer Address | GRAND RAPIDS MI US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2009-12-29 |