MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3000 HBO VENTILATOR; HYPERBARIC VENTILATOR

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

The ventilator was returned by the customer and evaluated and the reported issue was verified.Sechrist technician found that the set screws were loosened on the master control knob and the knob was removed.Severe scratch marks were observed at the end of the master valve assembly adjuster and brass shavings at its base, indicating the set screws had become loose during repeated use and were no longer fully secured onto the adjuster shaft.A device history review was performed on the 3000 - hbo vent, serial number (b)(4), manufactured on 04/03/2003.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no nonconformance that could cause or contribute to the reported issue.This report is submitted to comply with mdr malfunction notice 76 fr 12743 requiring the reporting of incidents involving a life-supporting and/or life-sustaining device.

Event Description

It was reported that during pre-clinical check a ventilator the master on/off switch was not working.

• Brand Name: 3000 HBO VENTILATOR
• Type of Device: HYPERBARIC VENTILATOR
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807
• MDR Report Key: 7073316
• MDR Text Key: 94083470
• Report Number: 2020676-2017-00027
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2003
• 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