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

Model Number 799-EMVP-04-23

Device Problems Calibration Problem (2890); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device displayed "runtime calibration failure - 1051" and "airway pressure sensing failure - 1052" error messages.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Complainant indicated that the clinician obtained another device, serial number (b)(4), to continue treating the patient and the device displayed an "airway pressure sensing failure - 1052" error message.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, a zoll approved service provider received the device.The customer's report of an "airway pressure sensing failure - 1052" error message was observed during review of the device data logs.However, the device was put through extensive testing including full functional testing without duplicating the report.An internal inspection found no discrepancies.The customer?s report of a"runtime calibration failure - 1051" error message was unsubstantiated.Review of the device forensic files found no evidence of the error occuring anywhere in the memory.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
• Type of Device: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11596016
• MDR Text Key: 243182190
• Report Number: 1220908-2021-00961
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 799-EMVP-04-23
• Device Catalogue Number: 799-EMVP-04-23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1