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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 No Display/Image (1183)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during biomed testing, the device powered on without display.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.
 
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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 Key8278610
Report Number1220908-2019-00135
Device Sequence Number14033857
Product Code CBK
UDI-Device Identifier00847946020767
UDI-Public00847946020767
Combination Product (Y/N)N
Initial Reporter CountryCN
PMA/510(K) Number
K111473
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/04/2019
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-EMVP-05
Device Catalogue Number799-EMVP-05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/04/2019
Supplement Date Received by Manufacturer01/04/2019
Initial Report FDA Received Date01/25/2019
Supplement Report FDA Received Date02/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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