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

Model Number	799-EGL2-02
Medical Device Problem Codes	Improper Flow or Infusion (2954); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the device stopped ventilating and displayed an unknown error message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical singapore evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including final testing and o2 supply testing without duplicating the report.The device was recertified and returned to the customer.The device logs were not available for review.No trend is associated with reports of this type.

• 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: 10803323
• Report Number: 1220908-2020-03512
• Device Sequence Number: 19650153
• Product Code: CBK
• UDI-Device Identifier: 00847946020910
• UDI-Public: 00847946020910
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• 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): 10/18/2020

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-EGL2-02
• Device Catalogue Number: 799-EGL2-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/18/2020
• Supplement Date Received by Manufacturer: 10/18/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1