Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DANYANG SUNMED HEALTHCARE CORP DYNAREX CPR SHIELD WITH ONE WAY VALVE; CPF FAVE SHIELD
  • 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
 

DANYANG SUNMED HEALTHCARE CORP DYNAREX CPR SHIELD WITH ONE WAY VALVE; CPF FAVE SHIELD Back to Search Results
Model Number 4921
Device Problems Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 06/04/2014
Event Type  malfunction  
Event Description
Distributor inspected the device and found the labeling on the device, an instruction for use printed on the cpr shield ("this side up"), was printed on the wrong side of the device.
 
Manufacturer Narrative
There were no complaints with this labeling issue in the past.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DYNAREX CPR SHIELD WITH ONE WAY VALVE
Type of Device
CPF FAVE SHIELD
Manufacturer (Section D)
DANYANG SUNMED HEALTHCARE CORP
danyang 2123 00
CH  212300
Manufacturer Contact
no. 3 bei er huan
danyang 21230-0
MDR Report Key4073212
MDR Text Key21170689
Report Number2431014-2014-00001
Device Sequence Number1
Product Code CBP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052743
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Remedial Action Recall
Type of Report Initial
Report Date 06/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number4921
Device Catalogue Number4921
Device Lot Number28619, 28621
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2014
Distributor Facility Aware Date06/04/2014
Device Age3 MO
Event Location Other
Date Manufacturer Received05/12/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-