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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INVIVO; OXIMETER
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PHILIPS MEDICAL SYSTEMS INVIVO; OXIMETER Back to Search Results
Model Number 3160
Device Problems Incorrect Or Inadequate Test Results (2456); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2016
Event Type  malfunction  
Event Description
After the patient had received some pre-anesthesia, he was moved into the mri room.At that time he was placed on the co2 monitor but it didn't function correctly.The biomed was called and responded but also could not get an accurate reading.Manufacturer response for invivo co2 monitor, invivo (per site reporter): our biomed department spoke with rep.They suggested changing the water filter.This was done and resumed working but it had been changed in past 3 months.Recommendation from manufacturer is every six months.We continue to have intermittent problems with the equipment.The issue is sporadic and often cannot be reproduced later by biomed.In this instance biomed came to mri and was unable to get the co2 monitor to function correctly.
 
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Brand Name
INVIVO
Type of Device
OXIMETER
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
MDR Report Key6240728
MDR Text Key64458465
Report Number6240728
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number3160
Device Catalogue Number865323
Other Device ID NumberMRI MONITOR
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2016
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NONE KNOWN; OTHER, (B)(6) IN FOR MRI UNDER CONSCIOUS SEDATION
Patient Age3 YR
Patient Weight15
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