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

Model Number 799-EMVP-04

Device Problems Use of Device Problem (1670); Calibration Problem (2890)

Patient Problem Death (1802)

Event Date 04/01/2020

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device displayed a "critical alarm warning" message.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.Please reference medwatch report 1220908-2020-01233 for a similar event reported from the same customer.

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device displayed a "runtime calibration failure - 1051" message.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.Please reference medwatch report 1220908-2020-01233 for a similar event reported from the same customer.

Manufacturer Narrative

Device evaluation: the device was returned to zoll medical corporation; the customers report was duplicated and attributed to a faulty autocal valve on the smart pneumatic module board.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
• Type of Device: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9993029
• MDR Text Key: 188742048
• Report Number: 1220908-2020-01117
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946020620
• UDI-Public: 00847946020620
• Combination Product (y/n): N
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 799-EMVP-04
• Device Catalogue Number: 799-EMVP-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death