Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION UNI-VENT MODEL, 731; VENTILATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL MEDICAL CORPORATION UNI-VENT MODEL, 731; VENTILATOR Back to Search Results
Model Number 799-AEV1-01
Medical Device Problem Code Calibration Problem (2890)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed a "runtime calibration failure - 1051" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and attributed to the autocal valve on the smart pneumatic module board.The smart pneumatic module board was replaced.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNI-VENT MODEL, 731
Common Device Name
VENTILATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key9521397
Report Number1220908-2019-04057
Device Sequence Number16897100
Product Code CBK
UDI-Device Identifier00847946020651
UDI-Public00847946020651
Combination Product (Y/N)N
Initial Reporter StateNY
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) 12/05/2019
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 Manufacturer12/20/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/05/2019
Supplement Date Received by Manufacturer12/05/2019
Initial Report FDA Received Date12/26/2019
Supplement Report FDA Received Date01/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-