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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI; OXIMETER

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ST PAUL BCI; OXIMETER Back to Search Results
Model Number 1303
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information received a smiths medicsl patient monitoring|bci oximeter disposables reported sensors show defects after 1 to 2 days in use.Customer stated they do not dissipate, provide incorrect measure values and the cables of new sensors are already exposed as missing cable covers.
 
Manufacturer Narrative
Other text: device was supplied.Further investigation will be done by the supplier.No further information is available.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The device sometimes had no readings, wire interruption, adhesive tape was thin and stretched the root cause of the reported issue was found to be a user interface problem.Device will be returned to the supplier.
 
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Brand Name
BCI
Type of Device
OXIMETER
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12294086
MDR Text Key265592804
Report Number3012307300-2021-08213
Device Sequence Number1
Product Code DQA
UDI-Device Identifier15019517042511
UDI-Public15019517042511
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K920082
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2023
Device Model Number1303
Device Catalogue Number1303
Device Lot Number1952-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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