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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 Codes Use of Device Problem (1670); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report was duplicated and attributed to a faulty transducer on the smart pneumatic board.The device was rectified 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 a routine shift check by a clinician, the device displayed "off set self check failure - 1174" and "airway pressure sensing failure - 1052" messages.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 Key9338032
Report Number1220908-2019-03536
Device Sequence Number19295237
Product Code CBK
UDI-Device Identifier00847946020651
UDI-Public00847946020651
Combination Product (Y/N)N
Initial Reporter StateMO
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) 10/29/2019
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 Health Professional
Device Model Number799-AEV1-01
Device Catalogue Number799-AEV1-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2019
Initial Report FDA Received Date11/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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