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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 a routine shift check by a clinician, the device displayed a "runtime calibration failure-1051" message complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty autocal valve on the smart pneumatic module.Analysis for reports of this type has not identified an increase in trend.
 
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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 Key7347830
Report Number1220908-2018-00675
Device Sequence Number18853068
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) 02/26/2018
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 Manufacturer03/14/2018
Initial Date Received by Manufacturer 02/26/2018
Supplement Date Received by Manufacturer02/26/2018
Initial Report FDA Received Date03/18/2018
Supplement Report FDA Received Date04/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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