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

Model Number 799-AEB1-00-01

Device Problem Failure to Power Up (1476)

Patient Problem Inadequate Osseointegration (2646)

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 during a routine shift check by a clinician, the device would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation; the customer's report was duplicated and attributed to a faulty capacitor 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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 9867158
• MDR Text Key: 184738161
• Report Number: 1220908-2020-00726
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00847946024192
• UDI-Public: 00847946024192
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 799-AEB1-00-01
• Device Catalogue Number: 799-AEB1-00-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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