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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL REVEL, ENGLISH SERVICE REPAIR
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VYAIRE MEDICAL REVEL, ENGLISH SERVICE REPAIR Back to Search Results
Model Number REVEL, ENGLISH SERVICE REPAIR
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2024
Event Type  malfunction  
Event Description
It was reported that the reset config alarm had occurred on the revel ventilator.The device hours were reset and a new main board has been ordered.No patient involvement reported.
 
Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81: other: at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
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Brand Name
REVEL, ENGLISH SERVICE REPAIR
Type of Device
REVEL
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
sandra valencia
510 technology drive
irvine, CA 92618
2402760001
MDR Report Key18865690
MDR Text Key337466061
Report Number2021710-2024-18861
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070594
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberREVEL, ENGLISH SERVICE REPAIR
Device Catalogue Number19260-001-99
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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