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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS BODY PC; CALCULATOR, PULMONARY FUNCTION DATA

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VYAIRE MEDICAL GMBH VYNTUS BODY PC; CALCULATOR, PULMONARY FUNCTION DATA Back to Search Results
Model Number VYNTUS BODY PC
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2023
Event Type  Injury  
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 was received.
 
Event Description
It was reported to vyaire medical that the door completely shattered during installation which resulted to small cuts on the arms, hands, and scalp of the field service representative.There was no patient involved as the event happened during installation.
 
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Brand Name
VYNTUS BODY PC
Type of Device
CALCULATOR, PULMONARY FUNCTION DATA
Manufacturer (Section D)
VYAIRE MEDICAL GMBH
leibnizstrasse 7 hoechberg, 97
hoechberg 97204
GM  97204
Manufacturer (Section G)
VYAIRE MEDICAL GMBH
leibnizstrasse 7
hoechberg 97201
GM   97201
Manufacturer Contact
erika bonilla
510 technology drive
irvine, CA 92618
MDR Report Key16770566
MDR Text Key313594057
Report Number9615102-2023-00134
Device Sequence Number1
Product Code BZC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVYNTUS BODY PC
Device Catalogue Number31797-001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/23/2023
Initial Date FDA Received04/19/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/06/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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