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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 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the unit had low reading.There was no patient harm associated with this event.
 
Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The sensor passed inspection with no faults found.Device history records report by the manufacturing site showed now issues during the production of this lot.The investigation found the device to function normally.Information has been added to the database and trends will continue to be monitored.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 Key9188775
MDR Text Key162971576
Report Number2936999-2019-00863
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 distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2020
Device Model Number186-0106
Device Catalogue Number186-0106
Device Lot Number1209181K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Date Manufacturer Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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