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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-AEV1-01
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The malfunction was observed during initial testing; however after disassembling the device to determine root cause, the malfunction was no longer seen.The device was put through extensive testing which included bench handling, functional stress testing, internal inspection, and calibration testing without duplicating the malfunction.The device passed the final test procedure, was recertified, and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during functional testing, the device's oxygen could be heard leaking internally.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key8605766
Report Number1220908-2019-01222
Device Sequence Number1857444
Product Code CBK
UDI-Device Identifier00847946020651
UDI-Public00847946020651
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K111473
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/23/2019
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-AEV1-01
Device Catalogue Number799-AEV1-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2019
Initial Report FDA Received Date05/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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