• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOE MEDICAL, INCORPORATED ULTRAVIEW DM3 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
 

ZOE MEDICAL, INCORPORATED ULTRAVIEW DM3 PATIENT MONITOR Back to Search Results
Model Number 91330
Device Problem Defective Alarm (1014)
Patient Problem Death (1802)
Event Date 04/13/2016
Event Type  Death  
Event Description
(b)(4) reports that the dm3 monitor (91330) failed to alarm for low nibp on patient that coded. Patient admit for cerebral infarction and heart disease. Patient had multiple stents. New stent @ (b)(6) on (b)(6) 2016. Admit to (b)(6) 2016 at 02:30. Patient code on (b)(6) 2016 approx. 09:10 in neuro unit on dm3. Patient code on (b)(6) 2016 approx. 10:34 in icu. Patient passed on (b)(6) 2016 at 15:20. Hosp. Risk manager still collecting data. Dm3 was removed from patient room by (b)(4) at request of nursing for testing. Monitor was turned off and defaulted back to spot mode. (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAVIEW DM3
Type of DevicePATIENT MONITOR
Manufacturer (Section D)
ZOE MEDICAL, INCORPORATED
460 boston street
topsfield MA 01983
Manufacturer (Section G)
ZOE MEDICAL, INCORPORATED
460 boston street
topsfield MA 01983
Manufacturer Contact
james chickering
460 boston street
topsfield, MA 01983
9788871410
MDR Report Key5766357
MDR Text Key48684569
Report Number3003294644-2016-00001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number91330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/01/2016 Patient Sequence Number: 1
-
-