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

Model Number 799-EMVP-01-01

Device Problems Failure to Power Up (1476); Communication or Transmission Problem (2896); Improper Flow or Infusion (2954)

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

Event Date 01/20/2024

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 49-year-old male patient, the device displayed an "internal comm failure - 1475" error message and stopped ventilating.Complainant indicated the crew power cycled the device to troubleshoot, however the unit would not power up.The following morning the device worked as intended.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report of "the device displayed an 'internal comm failure 1475' error message" was observed during review of the forensic memory log.However, the device was put through extensive testing without duplicating the report.An internal inspection found no discrepancies.The main lithium-ion battery was replaced as a precaution.The customer's report of the device stopped ventilating and then the unit would not power up was verified and attributed to the main lithium-ion battery.The main lithium-ion battery was replaced to remedy the report.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
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18685632
• MDR Text Key: 335210394
• Report Number: 1220908-2024-00429
• Device Sequence Number: 1
• Product Code: CBK
• 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: 01/22/2024

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
• Device Operator: Other
• Device Model Number: 799-EMVP-01-01
• Device Catalogue Number: 799-EMVP-01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2013
• 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
• Patient Age: 49 YR
• Patient Sex: Male