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); 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 a routine shift check by a clinician, the device displayed an "airway pressure sensing failure" message.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.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the reported malfunction was duplicated and attributed to a faulty transducer on the smart pneumatic module board.The smart pneumatic module board was replaced to remedy the reported malfunction.The device was rectified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed a "runtime calibration failure - 1051" error message.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
• MDR Report Key: 9256233
• Report Number: 1220908-2019-03300
• Device Sequence Number: 14090815
• Product Code: CBK
• UDI-Device Identifier: 00847946020675
• UDI-Public: 00847946020675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111473
• 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): 10/09/2019

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 Number: 799-EGL2-00
• Device Catalogue Number: 799-ELG2-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1