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: TELEFLEX HUDSON VOLDYNE2500 INCENTIVE SPIROMETER
  • 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
 

TELEFLEX HUDSON VOLDYNE2500 INCENTIVE SPIROMETER Back to Search Results
Catalog Number 8884719025
Device Problem Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2014
Event Type  malfunction  
Event Description
The complaint is reported as: the yellow indicator cup was sticking on the downward movement.The device would not reflect the patient's accurate breath force when starting a new breathing cycle.There was no harm to the patient.The patient condition was reported to be fine.
 
Manufacturer Narrative
A device history record (dhr) could not be conducted since the lot number was not provided.An assessment ((b)(4)) was conducted and no changes were required.The sample was not returned for evaluation, therefore, the complaint could not be confirmed.If the sample is received, a follow-up report will be submitted with the investigation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON VOLDYNE2500 INCENTIVE SPIROMETER
Type of Device
INCENTIVE SPIROMETER
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer Contact
warrenda peterson, ra
p.o. box 12600
rtp,, NC 27709
9193613959
MDR Report Key3896471
MDR Text Key4674079
Report Number3003898360-2014-00298
Device Sequence Number1
Product Code BWF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number8884719025
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-