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

Model Number	799-AEV1-03
Medical Device Problem Codes	Failure to Calibrate (2440); Failure of Device to Self-Test (2937); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed "off set self check failure, 1174" and a unknown "o2 valve failure" messages.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device problem code).Evaluation: the device was not returned to zoll medical corporation for evaluation.Instead, a zoll field representative evaluated the device at the customer's site.The customer's report was verified and the smart pneumatic module board was replaced to remedy the report.The device was recertified and returned to the customer.Reports of calibration testing nature are typically not submitted as there would be no potential for clinical impact.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed "off set self check failure - 1174" and failed o2 filter and leak check calibration testing.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: UNI-VENT, MODEL 731
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 13686327
• Report Number: 1220908-2022-00751
• Device Sequence Number: 5308428
• Product Code: CBK
• UDI-Device Identifier: 00847946020668
• UDI-Public: 00847946020668
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K111473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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-AEV1-03
• Device Catalogue Number: 799-AEV1-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown