MAUDE Adverse Event Report: IMPACT PRODUCTS UNI-VENT MODEL 731; VENTILATOR

Model Number 799-AEV1-01

Device Problems Failure to Power Up (1476); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that the main switch was stuck and the device was unable to be powered on.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical corporation; the malfunction was duplicated and the device's bezel assembly was replaced to resolve the malfunction.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): IMPACT PRODUCTS; 27 fairfield place; west caldwell NJ 07006
• Manufacturer Contact: 27 fairfield place; west caldwell, NJ 07006 ; 9738821212
• MDR Report Key: 5538890
• MDR Text Key: 41865036
• Report Number: 2242630-2016-00046
• 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: 03/14/2016

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-AEV1-01
• Device Catalogue Number: 799-AEV1-01
• Device Lot Number: N/A
• Other Device ID Number: 00847946020651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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