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

MAUDE Adverse Event Report: WELLSKY CORPORATION HCLL 2014 R2 CS

  • 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
 

WELLSKY CORPORATION HCLL 2014 R2 CS Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 01/30/2019
Event Type  Malfunction  
Event Description

It has been reported, that within the customer production environment, hcll 2014 r2 cs appeared to scan a unit as o+. During subsequent product modification processes, the application displayed the unit as o-. As a result, there is potential that the scanned unit may document a different blood type. Currently this event is not able to be reproduced and no other similar events have been reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHCLL 2014 R2 CS
Type of DeviceHCLL 2014 R2 CS
Manufacturer (Section D)
WELLSKY CORPORATION
11711 west 79th street
lenexa KS 66214
Manufacturer (Section G)
WELLSKY CORPORATION
11711 west 79th street
lenexa KS 66214
Manufacturer Contact
jon moeckel
11711 west 79th street
lenexa, KS 66214
9133071051
MDR Report Key11701707
MDR Text Key247226226
Report Number3006129391-2019-00002
Device Sequence Number1
Product Code MMH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberBK160066
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 02/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/21/2021 Patient Sequence Number: 1
-
-