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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL COMPACT COMPRESSOR SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)
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VYAIRE MEDICAL COMPACT COMPRESSOR SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE) Back to Search Results
Model Number COMPACT COMPRESSOR SYSTEM
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2020
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
The customer reported that the compact compressor mq5800 is not pushing out air to get the medicine to the patient.At this time, there is no information regarding patient harm associated with the reported event.
 
Manufacturer Narrative
Failure analysis: the device history record review show no deviation in manufacturers specifications.Since the actual failure sample is not available, the actual failure analysis on the defective return sample cannot be conducted.Therefore, no root cause could be determined.
 
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Brand Name
COMPACT COMPRESSOR SYSTEM
Type of Device
NEBULIZER (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key10261013
MDR Text Key200047743
Report Number8030673-2020-00109
Device Sequence Number1
Product Code CAF
UDI-Device Identifier00822383579153
UDI-Public(01)00822383579153(10)13M1802022620
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCOMPACT COMPRESSOR SYSTEM
Device Catalogue Number23181-001
Device Lot Number13M1802022620
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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