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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD BIS; ELECTRODE, CUTANEOUS
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CELESTICA ELECTRONICS S PTE LTD BIS; ELECTRODE, CUTANEOUS Back to Search Results
Model Number 186-0106
Device Problem Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
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.
 
Manufacturer Narrative
Evaluation summary: two devices were received for evaluation.The reported symptom could not be duplicated for either sensor.The sensor was connected to the lot code tester and the lot code was verified.The device failed to meet specification as it was received or made available for evaluation.The investigation found the device to function normally.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
BIS
Type of Device
ELECTRODE, CUTANEOUS
Manufacturer (Section D)
CELESTICA ELECTRONICS S PTE LTD
no. 6 serangoon north avenue 5
singapore 55491 0
SG  554910
MDR Report Key7518926
MDR Text Key108417957
Report Number2936999-2018-00347
Device Sequence Number1
Product Code GXY
UDI-Device Identifier20884521134307
UDI-Public20884521134307
Combination Product (y/n)N
PMA/PMN Number
K093183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Model Number186-0106
Device Catalogue Number186-0106
Device Lot Number0829171K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2019
Date Manufacturer Received01/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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