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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION UNI-VENTILATOR 731
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ZOLL MEDICAL CORPORATION UNI-VENTILATOR 731 Back to Search Results
Model Number 799-EGL2-02
Medical Device Problem Code Failure of Device to Self-Test (2937)
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 displayed an "off set self check failure - 1174" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The customer's report was observed upon initial testing by a zoll approved service provider.However, until zoll medical corporation receives the device, root cause evaluation cannot be performed.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
UNI-VENTILATOR 731
Common Device Name
VENTILATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11065752
Report Number1220908-2020-04175
Device Sequence Number2586324
Product Code CBK
UDI-Device Identifier00847946020910
UDI-Public00847946020910
Combination Product (Y/N)N
PMA/510(K) Number
K111473
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/06/2020
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-EGL2-02
Device Catalogue Number799-EGL2-02
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/06/2020
Supplement Date Received by Manufacturer12/06/2020
Initial Report FDA Received Date12/23/2020
Supplement Report FDA Received Date01/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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