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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION UNI-VENT, MODEL 731; VENTILATOR
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ZOLL MEDICAL CORPORATION UNI-VENT, MODEL 731; VENTILATOR Back to Search Results
Model Number 799-EGB2-01-01
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed the pre-pressure check.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
 
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Brand Name
UNI-VENT, MODEL 731
Common Device Name
VENTILATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11457141
Report Number1220908-2021-00674
Device Sequence Number3522749
Product Code CBK
UDI-Device Identifier00847946026592
UDI-Public00847946026592
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K111473
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/17/2021
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
Operator of Device Other
Device Model Number799-EGB2-01-01
Device Catalogue Number799-EGB2-01-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Received by Manufacturer 02/17/2021
Supplement Date Received by Manufacturer02/17/2021
Initial Report FDA Received Date03/10/2021
Supplement Report FDA Received Date04/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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