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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON AQUAPAK 640 SW, 650 ML W/040 ADAPTOR, FRE; BUBBLE HUMIDIFIER
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TELEFELX MEDICAL HUDSON AQUAPAK 640 SW, 650 ML W/040 ADAPTOR, FRE; BUBBLE HUMIDIFIER Back to Search Results
Catalog Number 006-40F
Device Problems Stretched (1601); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the aquapak made a whistle sound when starting the flow of oxygen and the aquapak is expanding when the pressure goes up.
 
Manufacturer Narrative
Product usage at the time of the alleged event is unknown at the time of this report.The device sample was not returned for evaluation at the time of this report.
 
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Brand Name
HUDSON AQUAPAK 640 SW, 650 ML W/040 ADAPTOR, FRE
Type of Device
BUBBLE HUMIDIFIER
Manufacturer (Section D)
TELEFELX MEDICAL
arlington heights IL
Manufacturer (Section G)
TELEFELX
900 west university dr.
Manufacturer Contact
margie burton, rn, reg affairs
po box 12600
durham, NC 27709
9194334965
MDR Report Key3868426
MDR Text Key4510749
Report Number1417411-2014-00031
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2014
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 Number006-40F
Device Lot Number159136
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/17/2014
Initial Date FDA Received05/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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