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 NORTH AMERICA LLC SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER
  • 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 NORTH AMERICA LLC SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER Back to Search Results
Model Number 453564024481
Device Problems Erratic or Intermittent Display (1182); Poor Quality Image (1408); No Device Output (1435)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the device displayed color bar, then froze and powered off.It was unknown if the device was in clinical use at the time the issue was discovered.No adverse event or patient harm was reported.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the device displayed color bar, then froze and powered off.It was unknown if the device was in clinical use at the time the issue was discovered.No adverse event or patient harm was reported.
 
Manufacturer Narrative
The device was received by the philips bench repair and an evaluation was performed by the bench technician.The reported issue was confirmed and traced to a faulty mainboard.The small parts kit (lcd cable) and the nbp pump also had to be replaced for compatibility.The device was returned to the customer after parts replacement.
 
Event Description
It was reported to philips that the device displayed color bar, then froze and powered off.This was discovered by the biomedical engineer onsite while conducting maintenance on the unit.The device was not in use on a patient at the time of event, there was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER
Type of Device
SURESIGNS VM8 IBP EXCHG UNIT W/RECORDER
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
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key13599664
MDR Text Key286136854
Report Number1218950-2022-00161
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00884838000087
UDI-Public00884838000087
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
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 Number453564024481
Device Catalogue Number453564024481
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2022
Initial Date FDA Received02/25/2022
Supplement Dates Manufacturer Received04/24/2022
Supplement Dates FDA Received05/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-