Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 VM6; COMPACT PORTABLE PATIENT MONITORS
  • 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 VM6; COMPACT PORTABLE PATIENT MONITORS Back to Search Results
Model Number 863064
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer contacted the customer care solution center and alleged that the display was broken on the complaint device and was missing the screws and requested support.The complaint device was not in clinical use at the time that the issue was discovered.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VM6
Type of Device
COMPACT PORTABLE PATIENT MONITORS
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key9982677
MDR Text Key188649257
Report Number1218950-2020-02415
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K082280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2020
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 Number863064
Device Catalogue Number863064
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/20/2020
Initial Date FDA Received04/21/2020
Supplement Dates Manufacturer Received04/20/2020
Supplement Dates FDA Received04/24/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-