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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION Z VENT; VENTILATOR, CONTINUOUS, FACILITY USE
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ZOLL MEDICAL CORPORATION Z VENT; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 799-EGB2-01-01
Device Problems Defective Component (2292); No Pressure (2994)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Event Description
Zoll ventilator would not pass the pre-use check, it would not pressurize, failed to work.Ventilator had to be switched out for transport.Manufacturer response for ventilator, continuous, facility use, z vent (per site reporter) we are having weekly updates with no resolution to the frequent failures of these zoll transport ventilators.The company has identified a spring valve that is failing but not the reason behind.We continue to have weekly meetings and they have supported with loaner ventilators (which have also failed).
 
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Brand Name
Z VENT
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11235821
MDR Text Key228880006
Report Number11235821
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2021
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
Device Operator Health Professional
Device Model Number799-EGB2-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer01/27/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age22630 DA
Patient Weight56
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