BIS 186-0106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-05-16 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.

Event Text Entries

[108417957] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[108417958] According to the reporter, during the procedure, the device provided low readings. The user concluded the error because they did not use too heavy dosage of anesthetic. The customer reported no injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2018-00347
MDR Report Key7518926
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-05-16
Date of Report2019-02-21
Date of Event2018-04-27
Date Mfgr Received2019-01-24
Device Manufacturer Date2017-08-29
Date Added to Maude2018-05-16
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 ContactAVI KLUGER
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone3035306582
Manufacturer G1CELESTICA ELECTRONICS S PTE LTD
Manufacturer StreetNO. 6 SERANGOON NORTH AVENUE 5
Manufacturer CitySINGAPORE 554910
Manufacturer CountrySG
Manufacturer Postal Code554910
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIS
Generic NameELECTRODE, CUTANEOUS
Product CodeGXY
Date Received2018-05-16
Returned To Mfg2019-01-12
Model Number186-0106
Catalog Number186-0106
Lot Number0829171K
Device Expiration Date2019-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCELESTICA ELECTRONICS S PTE LTD
Manufacturer AddressNO. 6 SERANGOON NORTH AVENUE 5 SINGAPORE 554910 SG 554910


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.