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

Model Number 799-EMVP-04-01

Device Problem Communication or Transmission Problem (2896)

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

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 during a routine shift check by a clinician, the device displayed an "internal comm failure -1474" message.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to a zoll approved service provider for evaluation.The customer's report was observed during initial testing.However, the report could not be duplicated.The device is expected to be returned to zoll medical corporation.Analysis of reports of this type has not identified an increase in trend.

Manufacturer Narrative

The device was returned to zoll medical corporation; the customer's report was duplicated and attributed to fractured solder on an integrated circuit on the smart pneumatic module.The smart pneumatic module was replaced to remedy the report.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: 11378509
• MDR Text Key: 234919252
• Report Number: 1220908-2021-00534
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946023423
• UDI-Public: 00847946023423
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 799-EMVP-04-01
• Device Catalogue Number: 799-EMVP-04-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1