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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN OXIBAND, PEDIATRIC/INFANT; PULSE OXIMETER SENSOR

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COVIDIEN OXIBAND, PEDIATRIC/INFANT; PULSE OXIMETER SENSOR Back to Search Results
Model Number OXI-P/I
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The customer did not retain the sensor.Complaint trends will continue to be monitored.
 
Event Description
The oxiband sensor showed low spo2 readings on a pediatric patient when used with a nellcor n65 pulse oximeter.The customer does not know the date of the event.There was no patient harm.
 
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Brand Name
OXIBAND, PEDIATRIC/INFANT
Type of Device
PULSE OXIMETER SENSOR
Manufacturer (Section D)
COVIDIEN
blvd. insurgentes parcela #37
tijuana, bc
MX 
Manufacturer (Section G)
COVIDIEN
blvd. insurgentes parcela #37
tijuana, bc
MX  
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5258972
MDR Text Key32500842
Report Number2936999-2015-01021
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012891
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/10/2015
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 Health Professional
Device Model NumberOXI-P/I
Device Catalogue NumberOXI-P/I
Device Lot Number143460198XH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2015
Initial Date FDA Received12/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2014
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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