UROSKOP OMNIA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-04 for UROSKOP OMNIA manufactured by Siemens Ag/siemens Healthcare Gmbh.

Event Text Entries

[137704827] Everything was ready to go in the room for surgery and pt had already been put to sleep but when the surgery started the surgeon was not able to take x-ray, multiple attempts to fix the problem but still unable to, so new bed and x-ray machine had to be brought to the room. Routine bed maintenance completed on table in or one day prior to incident. This case was the first case performed after the bed maintenance. Routine procedure was to be performed and patient positioned as usual. When surgeon was trying to get x-ray image necessary to proceed, image was very unclear and then went black. Numerous attempts were made to get image by the surgeon without success and with the same result. Maintenance was immediately informed and brought to the or. Unable to diagnose the problem decision was made to transfer the patient to another or table in the same room and bring in a portable c-arm. This involved breaking down the sterile field, repositioning and utilization of an increased amount of disposable goods for the case. The patient was under anesthesia for an increased amount of time (approximately 45-60 minutes). I have requested a detailed report from the company who fixed the bed and have not yet received it.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8385831
MDR Report Key8385831
Date Received2019-03-04
Date of Report2018-12-20
Date of Event2018-12-12
Report Date2018-12-20
Date Reported to FDA2018-12-20
Date Reported to Mfgr2019-03-04
Date Added to Maude2019-03-04
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUROSKOP OMNIA
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Product CodeJAA
Date Received2019-03-04
Model NumberUROSKOP OMNIA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS AG/SIEMENS HEALTHCARE GMBH
Manufacturer Address2 EDGEWATER DRIVE NORWOOD MA 02062 US 02062


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-04

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