• 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 Break (1069); Device Fell (4014)
Patient Problem Injury (2348)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete. (b)(6).
 
Event Description
The customer reported that there was a broken notch on the case, and an x2 device fell out of the m3015a. The customer was injured as a result of the device falling out of the clip. The extent of the injury was not available at the time of the report.
 
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 Key8320037
MDR Text Key135514686
Report Number9610816-2019-00042
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00884838021556
UDI-Public(01)00884838021556
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K993383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3015A
Device Catalogue Number862393
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 Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2017
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: 02/08/2019 Patient Sequence Number: 1
-
-