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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS HOLTER SOFTWARE
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PHILIPS NORTH AMERICA LLC PHILIPS HOLTER SOFTWARE Back to Search Results
Model Number 860292
Device Problem Date/Time-Related Software Problem (2582)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Event Description
Customer reported some of their studies are not being correctly flagged as read even though the doctor is reading them.For one study, when searching for a patient study taken on one date, a study for a different date (same patient) appears and vice versa.A second study had only the last name of the patient and the first name was added later.No patient harm or injury was reported.It is unknown if the device was in use at time of event.
 
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Brand Name
PHILIPS HOLTER SOFTWARE
Type of Device
PHILIPS HOLTER SOFTWARE
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
tara mackinnon
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key14759288
MDR Text Key294609540
Report Number1218950-2022-00504
Device Sequence Number1
Product Code MLO
UDI-Device Identifier00884838000469
UDI-Public00884838000469
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K010949
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number860292
Device Catalogue Number860292
Was Device Available for Evaluation? No
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? No
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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