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

Model Number	799-EGB2-01-01
Medical Device Problem Codes	Mechanical Problem (1384); 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 received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed "self check failure - 1003" and "compressor failure - 1001" error messages.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the customer's report of "compressor failure 1001" was duplicated and the compressor was replaced to resolve the report.The customer's report of "self check failure 1003" was observed during review of the device's forensic log.The device was put through extensive testing without duplicating the report.An internal inspection found foreign substance on the flow screens.The flow screens were replaced as a precaution.The device was recertified and returned to the customer.Analysis for 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: 10945359
• Report Number: 1220908-2020-03828
• Device Sequence Number: 16941392
• Product Code: CBK
• UDI-Device Identifier: 00847946026592
• UDI-Public: 00847946026592
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/12/2020

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-EGB2-01-01
• Device Catalogue Number: 799-EGB2-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1