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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-EGL2-00
Medical Device Problem Code Activation Problem (4042)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device did not respond to the front panel controls.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 product has not been returned to zoll for evaluation.
 
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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 Key9437226
Report Number1220908-2019-03743
Device Sequence Number2387660
Product Code CBK
UDI-Device Identifier00847946020675
UDI-Public00847946020675
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K111473
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/18/2019
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-EGL2-00
Device Catalogue Number799-ELG2-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/18/2019
Supplement Date Received by Manufacturer11/18/2019
Initial Report FDA Received Date12/09/2019
Supplement Report FDA Received Date12/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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