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

Model Number	799-EGL2-02
Medical Device Problem Code	Failure of Device to Self-Test (2937)
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 displayed an "off set self check failure - 1174" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The customer's report was verified at a zoll approved service provider and attributed to the smart pneumatic module board.A replacement smart pneumatic module board was sent and will be repaired onsite.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The smart pneumatic module assembly was returned to zoll medical corporation for evaluation.The customer's report was duplicated and the board was scrapped.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: 10729447
• Report Number: 1220908-2020-03329
• Device Sequence Number: 11544595
• Product Code: CBK
• UDI-Device Identifier: 00847946020910
• UDI-Public: 00847946020910
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Followup
• Report Date (Section B): 10/02/2020

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: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 10/02/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/16/2020; 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1