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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE LITER BAG, 60CM H2O PO; HYPERINFLATION BAG SYSTEM

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VYAIRE MEDICAL AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE LITER BAG, 60CM H2O PO; HYPERINFLATION BAG SYSTEM Back to Search Results
Model Number AIRLIFE¿ BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE ½ LITER BAG, 60CM H2O POP
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported that the baby safe hyp inf, 5l, 60cmh20, mano nrpr experienced manometer was stuck, not allowing the bag to refill properly.As of this time, there is no information regarding patient involvement associated with this reported event.
 
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Brand Name
AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE LITER BAG, 60CM H2O PO
Type of Device
HYPERINFLATION BAG SYSTEM
Manufacturer (Section D)
VYAIRE MEDICAL
510 technology dr
irvine IL 92618
MDR Report Key12643816
MDR Text Key281096053
Report Number8030673-2021-00202
Device Sequence Number1
Product Code BZD
UDI-Device Identifier10190752145894
UDI-Public(01)10190752145894(10)4179972
Combination Product (y/n)N
PMA/PMN Number
K911465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 09/20/2021
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 Health Professional
Device Model NumberAIRLIFE¿ BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE ½ LITER BAG, 60CM H2O POP
Device Catalogue Number5504B
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/20/2021
Initial Date FDA Received10/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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