• 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 X3

  • 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 X3 Back to Search Results
Model Number 867030
Device Problems Defective Alarm (1014); No Audible Alarm (1019)
Patient Problem Tachycardia (2095)
Event Date 01/15/2024
Event Type  Injury  
Event Description
It was reported the unit didn't alarm for bed 29 at circa 12pm when the patient was tachycardic and resulted in the patient needed resuscitation.The device was reported to be in use on a patient at the time of event.An adverse event was reported.
 
Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.Reporting institution phone: (b)(6).Reporter phone: (b)(6).
 
Manufacturer Narrative
A philips remote service engineer (rse) spoke by telephone support with the customer who provided device logs for review.The rse reviewed the logs, which showed the unit was alarming and re-alarming during the time of the reported event.Based on the information available and the testing conducted, the cause of the reported problem was the user, as the alarms were acknowledged at the bedside and central station.The reported problem was not confirmed, as the alarms sounded correctly.The investigation concludes that no further action is required at this time.The device remains at the customer site.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTELLIVUE X3
Type of Device
INTELLIVUE X3
Manufacturer (Section D)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM  71034
Manufacturer (Section G)
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
Manufacturer Contact
hauke schik
hewlett-packard-str. 2,
b1-3/d6
boblingen 71034
GM   71034
7031463203
MDR Report Key18669605
MDR Text Key334913714
Report Number9610816-2024-00032
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K171801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number867030
Device Catalogue Number867030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2024
Initial Date FDA Received02/08/2024
Supplement Dates Manufacturer Received01/31/2024
Supplement Dates FDA Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
-
-