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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL AEV (TAN, COMMERCIAL); VENTILATOR
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ZOLL MEDICAL CORPORATION MODEL AEV (TAN, COMMERCIAL); 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 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 biomed testing, the device failed the breath performance test.That is all the information available.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and the compressor was replaced to resolve the malfunction.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
MODEL AEV (TAN, COMMERCIAL)
Common Device Name
VENTILATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key9089022
Report Number1220908-2019-02759
Device Sequence Number2323267
Product Code CBK
UDI-Device Identifier00847946020651
UDI-Public00847946020651
Combination Product (Y/N)N
Initial Reporter StateSC
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) 08/29/2019
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 Other
Device Model Number799-AEV1-01
Device Catalogue Number799-AEV1-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/29/2019
Supplement Date Received by Manufacturer08/29/2019
Initial Report FDA Received Date09/19/2019
Supplement Report FDA Received Date11/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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