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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB VCARE MANUAL RESUSCITATOR; MANUAL EMERGENCY VENTILATOR - (RESUSCITATOR)- WITH MANOMETER
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VENTLAB VCARE MANUAL RESUSCITATOR; MANUAL EMERGENCY VENTILATOR - (RESUSCITATOR)- WITH MANOMETER Back to Search Results
Model Number AF5140MB-I
Device Problems Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964)
Patient Problems Death (1802); No Code Available (3191)
Event Date 10/13/2015
Event Type  Death  
Manufacturer Narrative
It was also mentioned that the same device was used on the patient during an intubation procedure a couple of days prior to the adverse event.The nurse demonstrated use of the affected device and we saw that the resus bag was not free flowing.We instructed the nurse to remove the filter from the bag and continue to squeeze the bag as normal.The bag flowed freely once the filter was removed.This demonstration indicated a functional resus bag with a filter attached that was not allowing air to pass through it.The hospital staff was then instructed to visually examine the filter since we observed that it was yellow in color.They confirmed that the filter was clogged.Since the resus bag functioned properly during the initial intubation days earlier and since it functioned properly during the video conference with the hospital staff after the filter was removed, the filter must have become clogged due to patient secretions from the earlier use that dried during the extended period between uses.The customer is not returning the affected device for further evaluation.Our evaluation concluded that a possible root cause is the improper use and monitoring of the product by hospital staff allowed the filter to become occluded.A clogged filter on a resus bag can cause the patient not to be able to exhale.
 
Event Description
It was reported that the resuscitation bag would not allow the patient to exhale.During our investigation, we had a video conference call with a nurse and risk manager from the health system on october 15, 2015.It was also mentioned that the same device was used on the patient during an intubation procedure a couple of days prior to the adverse event.The nurse demonstrated use of the affected device and we saw that the resus bag was not free flowing.We instructed the nurse to remove the filter from the bag and continue to squeeze the bag as normal.The bag flowed freely once the filter was removed.This demonstration indicated a functional resus bag with a filter attached that was not allowing air to pass through it.The hospital staff was then instructed to visually examine the filter since we observed that it was yellow in color.They confirmed that the filter was clogged.Since the resus bag functioned properly during the initial intubation days earlier and since it functioned properly during the video conference with the hospital staff after the filter was removed, the filter must have become clogged due to patient secretions from the earlier use that dried during the extended period between uses.
 
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Brand Name
VCARE MANUAL RESUSCITATOR
Type of Device
MANUAL EMERGENCY VENTILATOR - (RESUSCITATOR)- WITH MANOMETER
Manufacturer (Section D)
VENTLAB
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENLAB
2710 northridge nw suite a
grand rapids MI 49455
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598400
MDR Report Key5221384
MDR Text Key31073124
Report Number2246980-2015-00021
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D026373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberAF5140MB-I
Device Lot Number302500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
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