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

Model Number 799-EMVP-04

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/08/2017

Event Type  malfunction  

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 treat a patient (age & gender unknown), the device displayed a "replace circuit" message.Complainant indicated that the clinician was unable to ventilate the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive troubleshooting without duplicating the reported malfunction.The device was recertified and returned to the customer.It is noteworthy to mention the wye circuit used at the time of the reported event was not returned for evaluation.No trend is associated with reports of this type.

• Brand Name: UNI-VENT, 731 MODEL
• Type of Device: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 7155495
• MDR Text Key: 96114082
• Report Number: 1220908-2017-03362
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946020620
• UDI-Public: 00847946020620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 12/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1