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

Model Number	3600E
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HYPERBARIC CHAMBER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• MDR Report Key: 6095048
• Report Number: 2020676-2016-00013
• Device Sequence Number: 1021667
• Product Code: CBF
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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
• Operator of Device: Health Professional
• Device Model Number: 3600E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68