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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER

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NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; OXIMETER Back to Search Results
Model Number D-YS
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem Hypoxia (1918)
Event Date 05/08/2017
Event Type  Injury  
Manufacturer Narrative
The customer did not retain the lot number which determines the date of manufacture.
 
Event Description
Medtronic received a report during a medical procedure the dura-y sensor generated erratic readings.Customer alleged the patient developed hypoxemia due to the constant issues of the sensor which is for early detection of hypoxemia.
 
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Brand Name
NELLCOR
Type of Device
OXIMETER
Manufacturer (Section D)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX  22225
Manufacturer (Section G)
NELLCOR PURITAN BENNETT MEXICO SA
boulevard insurgentes 19030
tijuana 22225
MX   22225
Manufacturer Contact
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key6679767
MDR Text Key78761515
Report Number9610849-2017-05007
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K944760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial
Report Date 06/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD-YS
Device Catalogue NumberD-YS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2017
Initial Date FDA Received06/29/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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