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

Model Number	799-EGL2-00
Medical Device Problem Codes	Use of Device Problem (1670); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 while attempting to treat a patient (age & gender unknown), the device inappropriately shut down.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device stopped ventilating.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference section b5 and h6; device code.Evaluation results: the device was returned to zoll medical canada and the customer's report was not replicated or confirmed.The device was put through extensive testing including functional and stress testing without duplicating the report.An internal inspection found no discrepancies.The smart pneumatic module board was replaced as a precaution.The device was recertified and returned to the customer.Analysis of 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: 10140138
• Report Number: 1220908-2020-01748
• Device Sequence Number: 2164104
• Product Code: CBK
• UDI-Device Identifier: 00847946020675
• UDI-Public: 00847946020675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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-EGL2-00
• Device Catalogue Number: 799-ELG2-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1