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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-EMVP-01-01
Device Problem Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that the device displayed a "runtime calibration failure - 1051" error message.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing without duplicating the report.The smart pneumatic module board was replaced as a precaution.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
UNI-VENT, MODEL 731
Type of Device
VENTILATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11680578
MDR Text Key248172443
Report Number1220908-2021-01161
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00847946023416
UDI-Public00847946023416
Combination Product (y/n)N
PMA/PMN Number
K111473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 03/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number799-EMVP-01-01
Device Catalogue Number799-EMVP-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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