MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION UNI-VENT, MODEL 731; VENTILATOR

Model Number	799-EGB2-01-01
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 device was returned to zoll medical corporation; the customer's report was observed during review of the device's history log.The device was put through extensive testing including bench handling, internal inspection, tce/rce functionality testing, and stress testing, with test accessories without duplicating the report.The smart pneumatic module was replaced as a precaution.The device passed the final test procedure, was recertified, and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: UNI-VENT, MODEL 731
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10459929
• Report Number: 1220908-2020-02628
• Device Sequence Number: 16742013
• Product Code: CBK
• UDI-Device Identifier: 00847946026592
• UDI-Public: 00847946026592
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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 Number: 799-EGB2-01-01
• Device Catalogue Number: 799-EGB2-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1