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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-EMVP-05
Medical Device Problem Code Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Information (3190)
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 displayed an "air intake" message.No further information was available.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
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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 Key7365547
Report Number1220908-2018-00740
Device Sequence Number19262020
Product Code CBK
UDI-Device Identifier00847946020767
UDI-Public00847946020767
Combination Product (Y/N)N
Initial Reporter StateNY
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,Followup
Report Date (Section B) 03/05/2018
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-EMVP-05
Device Catalogue Number799-EMVP-05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2018
Initial Date Received by Manufacturer 03/05/2018
Supplement Date Received by Manufacturer03/05/2018
Initial Report FDA Received Date03/23/2018
Supplement Report FDA Received Date03/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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