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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-AEB1-00-01
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The customer's report was duplicated and attributed to a faulty integrated circuit on the smart pneumatic module (spm) board.The spm board 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.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device displayed an "internal comm failure -1175" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key19128688
MDR Text Key340569085
Report Number1220908-2024-01350
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00847946024192
UDI-Public00847946024192
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111473
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 04/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number799-AEB1-00-01
Device Catalogue Number799-AEB1-00-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/01/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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