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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BCI; OXIMETER

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NULL BCI; OXIMETER Back to Search Results
Model Number WW1090
Device Problems Deformation Due to Compressive Stress (2889); Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/1901
Event Type  malfunction  
Event Description
It was reported that the battery on a smiths medical oximeter cannot be charged.Strong heating and deformation of the battery casing.No patient involvement.
 
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Brand Name
BCI
Type of Device
OXIMETER
Manufacturer (Section G)
NULL
MDR Report Key11144552
MDR Text Key225993278
Report Number3012307300-2021-00242
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberWW1090
Device Catalogue NumberWW1090
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received01/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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