• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS COMPURECORD REL. F.0

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS COMPURECORD REL. F.0 Back to Search Results
Model Number 865230
Device Problems Computer Operating System Problem (2898); Data Problem (3196)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that compurecord data was incorrect. Recent findings that a software defect is the root cause of the incorrect compurecord data. The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOMPURECORD REL. F.0
Type of DeviceCOMPURECORD REL. F.0
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 Key10643097
MDR Text Key211436345
Report Number1218950-2020-05926
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00884838022942
UDI-Public(01)00884838022942
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K083413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number865230
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/07/2020 Patient Sequence Number: 1
-
-