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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD HEALTH BALLARD FLEX HME; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES

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HALYARD HEALTH BALLARD FLEX HME; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES Back to Search Results
Model Number 150
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Upon completion of the investigation; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).
 
Event Description
Halyard received a single report that referenced three different incidences, which were associated with separate units, involving one patient.This is the first of three reports.Refer to 8030647-2015-00009 for the first report.Refer to 8030647-2015-00010 for the second report.Refer to 8030647-2015-00011 for the third report.It was reported by the caregiver, that the heat moisture exchanger looks and smells different than the previous heat moisture exchanger and has a strong plastic odor that dissipates after it is allowed to air out for a few hours.The plastic also seems thinner.There have been three occurrences in the last two months where the "bars" of the plastic "cage" that surround the sponge have been split or broken apart and has led to a whistling sound as you can hear the air moving through and a decrease in the peak inspiratory pressure which is steady at 38.The caregiver noted a drop to 32 which was corrected after changing out the heat moisture exchanger.The settings are set at 50/14 and there have been no adverse effects or alarms at this setting.The caregiver has used the heat moisture exchanger for a long time and only recently had issues".
 
Manufacturer Narrative
The device history record for the reported lot number, 2015-02-10, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.One sample device was returned.Prior to decontamination, the sample was assessed for odor.No "plastic" odor was perceived.The flex tubing was cracked in the larger portion that surrounds the hme filter media.The crack occurred between the 4th and 5th segment in this section.The crack extended approximately half way around the diameter of the tubing.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
 
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Brand Name
BALLARD FLEX HME
Type of Device
VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
Manufacturer (Section D)
HALYARD HEALTH
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AB ULAX
merkuriusgatan 8
motala ostergotlands lan [se-05],
sweden GA 59132
SW   59132
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key4919654
MDR Text Key22456529
Report Number3011270181-2015-00009
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Report Date 08/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Caregivers
Device Model Number150
Device Catalogue Number991093816
Device Lot Number2015-02-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/27/2015
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
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