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

Model Number	799-EGL2-00
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 while attempting to treat a patient (age & gender unknown), the device displayed a "runtime calibration failure - 1051" error message.Complainant indicated that the clinician switched to manual ventilation and obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
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.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: 10140128
• Report Number: 1220908-2020-01650
• Device Sequence Number: 13994258
• 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: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1