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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-01-64
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device displayed "internal comm failure-1471"and "internal communication failure-3470" error messages.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to a zoll approved service provider for evaluation.The customer's report was observed and attributed to the front case housing assembly.The front case assembly was replaced to resolve the report.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 Key11216645
MDR Text Key229316201
Report Number1220908-2021-00071
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K111473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number799-EMVP-01-64
Device Catalogue Number799-EMVP-01-64
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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