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

MAUDE Adverse Event Report: HAEMONETICS CORPORATION TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER; TEG ANALYZER, 5000, 230V, 50HZ, FG

  • 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
 

HAEMONETICS CORPORATION TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER; TEG ANALYZER, 5000, 230V, 50HZ, FG Back to Search Results
Model Number 07-033
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
The field service technician inspected the device and replaced all electrical components and columns.The field service technician also performed all functional tests and confirmed that all functions passed.The unit is operating within manufacturing standards.
 
Event Description
On (b)(6) 2019 haemonetics was informed that during a quality check (qc) a teg analyzr, 5000, 60hz, fg started smoking and turned itself off.The analyzer was then unplugged.A patient was not at the time the event occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER
Type of Device
TEG ANALYZER, 5000, 230V, 50HZ, FG
Manufacturer (Section D)
HAEMONETICS CORPORATION
125 summer street
boston MA 02110
Manufacturer (Section G)
HAEMONETICS CORPORATION
125 summer street
boston MA 02110
Manufacturer Contact
shaun flanagan
125 summer street
boston, MA 02110
MDR Report Key9636263
MDR Text Key181541113
Report Number1219343-2020-00002
Device Sequence Number1
Product Code JPA
UDI-Device Identifier30812747018184
UDI-Public(01)30812747018184
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/03/2019
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 No Information
Device Model Number07-033
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2019
Initial Date FDA Received01/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-