BIS 186-0106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for BIS 186-0106 manufactured by Celestica Electronics S Pte Ltd.

Event Text Entries

[116076622] Occupation: health professional (hpro). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[116076623] According to the reporter, intraoperatively, an issue with the reading and impedance check occurred. The customer informed that the monitor was working normally and presented a value of 50. However, during the procedure, after 1h30, the monitor presented the value 5 with absence of electrical activity. It was reported that the sensor was replaced to resolve the reported issue without incident to the patient.
Patient Sequence No: 1, Text Type: D, B5


[132430649] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2936999-2018-00483
MDR Report Key7744367
Date Received2018-08-02
Date of Report2018-10-03
Date of Event2018-01-23
Date Mfgr Received2018-08-08
Date Added to Maude2018-08-02
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 Report0

Device Details

Brand NameBIS
Generic NameELECTRODE, CUTANEOUS
Product CodeGXY
Date Received2018-08-02
Model Number186-0106
Catalog Number186-0106
Lot Number0914161L
Device Expiration Date2018-03-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2018-08-02

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