PKG, 21IN VISION ELECT FLAT MONITOR 0240030930

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for PKG, 21IN VISION ELECT FLAT MONITOR 0240030930 manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[59860580] The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[59860581] It was reported that the montior cut out during a critical moment of the case.
Patient Sequence No: 1, Text Type: D, B5


[75020176] Alleged failure: cut out at a critical moment of the case. Probable root cause: scaler/descaler board; power supply; ac inlet board; connectors; firmware; switch board; available channel; software not properly upgraded by flashmaster; prescan incorrectly eliminates channels; use error. The product was not returned for investigation; therefore, the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[75020177] It was reported that the monitor cut out during a critical moment of the case.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2016-01063
MDR Report Key6095810
Date Received2016-11-11
Date of Report2017-05-09
Date of Event2016-10-18
Date Mfgr Received2016-10-19
Device Manufacturer Date2008-07-01
Date Added to Maude2016-11-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KIMBERLY LYNCH
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY-SAN JOSE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal Code95138
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePKG, 21IN VISION ELECT FLAT MONITOR
Generic NameCAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
Product CodeFWB
Date Received2016-11-11
Catalog Number0240030930
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY-SAN JOSE
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-11

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