STERIS OR TABLE/CMAX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for STERIS OR TABLE/CMAX manufactured by Steris Corporation.

Event Text Entries

[180617677] On (b)(6) 2020 at 3:30pm an operating room nurse noted a burning smell coming from one of the operating rooms. The nurse opened the door to the room and noted white smoke. She summoned other staff who noted the smoke was coming from the operating room cmax table. The operating room table was unplugged and engineering and biomedical were notified. The fire department was also notified and arrived on the scene. The fire department assisted with smoke evacuation and secured the area. There was no patient in the room at the time as cases were done for the day. All similar tables were removed from service. And evaluated by the vendor. No issues were identified. A silicon sealant was applied to the tables as it was though that fluid may have seeped into the pedestal base which is not impervious to fluid. There was a hysteroscopy case done in the room within 30 minutes of the smoke. There was about 300cc of fluid on the operating room floor which is typical for this type of case. The room had been cleaned and the floor was dry at the time of this event. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093104
MDR Report Key9732809
Date Received2020-02-19
Date of Report2020-02-14
Date of Event2020-02-07
Date Added to Maude2020-02-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTERIS OR TABLE/CMAX
Generic NameTABLE, OPERATING-ROOM, ELECTRICAL
Product CodeGDC
Date Received2020-02-19
Returned To Mfg2020-02-11
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSTERIS CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-19

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