• 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 MICROSTREAM CO2 EXTENSION

  • 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 MICROSTREAM CO2 EXTENSION Back to Search Results
Model Number M3015A
Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
A customer emergency medical technician (emt) reported that the etco2 module did not work as expected, while patient was in cardiac arrest. The patient was in cardiac arrest and intubated in the field by ems prior to arrival to the hospital. When the customer staff attempted to use etco2 module, no measurement or waveform displayed, despite using proper filter tubing. The staff noticed an error message at the bottom of monitor that indicated calibration was required. When a clinical specialist attached the module to another mx700, an inop message "c02 equip malf" and "co2 occlusion" displayed. Even when the monitor was placed in demo mode, no measurement for etco2 displayed. The emt stated that the staff used a portable etco2 monitor located on their code cart. The patient was transferred upstairs to inpatient unit, where patient subsequently passed away. The emt did not state that the malfunction of this equipment contributed to the death of the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICROSTREAM CO2 EXTENSION
Type of DeviceMICROSTREAM CO2 EXTENSION
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM 71034
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
hewlett-packard str.2
boeblingen 71034
GM   71034
MDR Report Key8403197
MDR Text Key138208069
Report Number9610816-2019-00068
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993383
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 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3015A
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 Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2014
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: 03/08/2019 Patient Sequence Number: 1
-
-