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

Model Number	799-EGL2-00
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 product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed a "airway pressure sensing failure - 1052" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
Additional Manufacturer Narrative
The malfunction was duplicated and attributed to a faulty airway pressure transducer on the smart pneumatic module.The smart pneumatic module was replaced.The device was recertified and returned to the customer.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: 8125449
• Report Number: 1220908-2018-03490
• Device Sequence Number: 1913242
• Product Code: CBK
• UDI-Device Identifier: 00847946020675
• UDI-Public: 00847946020675
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 11/12/2018

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: 06/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 11/12/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/19/2018; 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1