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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 Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty aw pressure transducer on the smart pneumatic module.The device was recertified 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 while attempting to treat a patient (age & gender unknown), the device displayed a "runtime calibration failure" message.Complainant indicated that the clinician manually ventilated and intubated the patient to continue treatment.Complainant did not indicate that there was any adverse effect to the patient due to 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 Key7874636
Report Number1220908-2018-02619
Device Sequence Number10819837
Product Code CBK
UDI-Device Identifier00847946020651
UDI-Public00847946020651
Combination Product (Y/N)N
Initial Reporter StateMI
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) 08/23/2018
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 Health Professional
Device Model Number799-AEV1-01
Device Catalogue Number799-AEV1-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/23/2018
Initial Report FDA Received Date09/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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