MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC OXYGEN CHAMBER; HYPERBARIC CHAMBER

Model Number 3600E

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Sechrist contacted initial reporter (b)(6) on october 13, 2016 to discuss this reported event.Ms.(b)(6) stated troubleshooting was performed via phone with one of our sechrist technicians on december 4, 2015; chamber ran through 5 cycles at varying depths and rates and unable to duplicate error "e301".Ms.(b)(6) stated that on december 7, 2015 someone by the name of (b)(6) (not a sechrist employee) evaluated and repaired the reported device.

Event Description

It was reported via medsun#(b)(4): no harm to patient.Treatment was complete when system error "e301" and alarm occurred.Patient safely removed from chamber and transported on the gurney to an adjoining room.Notified the national safety director of an acute and chronic wound care organization.Discussed events with service technician for the manufacturer.Chamber run through 5 cycles at varying depths and rates as advised by the manufacturer without duplication of error.Chamber not removed from unit, however, signage was placed on machine to remove from service until inspected.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working) device usage problem: device malfunction - that is, the device did not do what it was supposed to do.

• Brand Name: HYPERBARIC OXYGEN CHAMBER
• Type of Device: HYPERBARIC CHAMBER
• 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: victor arellano ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 6095048
• MDR Text Key: 59878347
• Report Number: 2020676-2016-00013
• Device Sequence Number: 1
• Product Code: CBF
• 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,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2010
• 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: 50 YR
• Patient Weight: 68