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 MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR
  • 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 MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR Back to Search Results
Model Number 865241
Device Problem Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Event Description
The customer reported a drop damage - broken cast hooking lug on the mounting arm.It is unknown if the device was in use monitoring a patient at the time of the event.No adverse event involving patient or user was reported.
 
Event Description
The customer reported a drop damage - broken cast hooking lug on the mounting arm.It is unknown if the device was in use monitoring a patient at the time of the event.No adverse event involving patient or user was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLIVUE MX700 PATIENT MONITOR
Type of Device
INTELLIVUE MX700 PATIENT MONITOR
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
MDR Report Key12148990
MDR Text Key260938443
Report Number9610816-2021-10216
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838029088
UDI-Public00884838029088
Combination Product (y/n)N
PMA/PMN Number
K150310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
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 Number865241
Device Catalogue Number865241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2021
Distributor Facility Aware Date07/02/2021
Initial Date Manufacturer Received 07/02/2021
Initial Date FDA Received07/12/2021
Supplement Dates Manufacturer Received07/02/2021
Supplement Dates FDA Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-