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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 Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed an "o2 compressor failure" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.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 Key7025199
Report Number1220908-2017-02879
Device Sequence Number11271751
Product Code CBK
UDI-Device Identifier00847946020767
UDI-Public00847946020767
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,Followup
Report Date (Section B) 10/23/2017
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 Manufacturer10/31/2017
Initial Date Received by Manufacturer 10/23/2017
Supplement Date Received by Manufacturer10/23/2017
Initial Report FDA Received Date11/13/2017
Supplement Report FDA Received Date12/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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