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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS V24/26 COMPONENT MONITORING SYSTEM; BEDSIDE MONITOR

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PHILIPS MEDICAL SYSTEMS V24/26 COMPONENT MONITORING SYSTEM; BEDSIDE MONITOR Back to Search Results
Model Number M1205A
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that there was no sound coming from the m1205a device and there was a speaker malfunction ¿inop¿ being displayed.No death or patient /user injury or harm was reported.
 
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Brand Name
V24/26 COMPONENT MONITORING SYSTEM
Type of Device
BEDSIDE MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8277009
MDR Text Key134192080
Report Number1218950-2019-00744
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/13/2018
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 NumberM1205A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/13/2018
Initial Date FDA Received01/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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