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

Model Number 799-EMVP-01-23

Device Problem Use of Device Problem (1670)

Patient Problems Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)

Event Date 08/16/2020

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 stopped ventilating.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient went into respiratory arrest.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference sections b1, b5, h1 and h6:patient code.Evaluation results: the device was returned to a zoll approved service provider for evaluation.Review of the data logs showed messages indicating that fresh gas intake fault- 2030 occurred and was escalated to fresh gas intake fault- 1030 due to a blockage in the fresh gas/emergency air inlet, which causes high pressure o2 to be unavailable to support ventilation.However, the device was put through 8 hours of full functional testing without duplicating a malfunction.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the device stopped ventilating.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.

Manufacturer Narrative

The device was returned to zoll medical corporation.The customer's report was observed during review of the device data logs.However, the device passed full functional testing and ventilating stress testing without duplicating the report.An internal inspection found no discrepancies.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: 10511473
• MDR Text Key: 206280745
• Report Number: 1220908-2020-02787
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 799-EMVP-01-23
• Device Catalogue Number: 799-EMVP-01-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/19/2020; 08/19/2020
• Supplement Dates FDA Received: 10/29/2020; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other