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

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 AL W/040 ADAPTOR; BUBBLE HUMIDIFIER

  • 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 MEDICAL HUDSON AQUAPAK 340 AL W/040 ADAPTOR; BUBBLE HUMIDIFIER Back to Search Results
Catalog Number 003-40
Device Problem Crack (1135)
Patient Problem No Code Available (3191)
Event Date 05/22/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the bottom of the bottle (device) cracked during use.The child was scared by the cracked bottle.Pt condition reported as fine.
 
Manufacturer Narrative
A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review was conducted.A review of manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.All-in-process qa inspections were acceptable.No sample available from the customer to investigate.Root cause unk.Teleflex will continue to monitor feedback from the customers on issue related to water bottle getting cracked prior to or during use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON AQUAPAK 340 AL W/040 ADAPTOR
Type of Device
BUBBLE HUMIDIFIER
Manufacturer (Section D)
TELEFLEX MEDICAL
arlington heights IL
Manufacturer (Section G)
TELEFLEX
900 west university dr.
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3950616
MDR Text Key4613435
Report Number1417411-2014-00041
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/30/2014
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 Other
Device Catalogue Number003-40
Device Lot Number044137
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/30/2014
Initial Date FDA Received06/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-