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

Model Number 21762

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 12/23/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Reported event is still pending evaluation.

Event Description

It was reported that during (hbot) a routine hyperbaric oxygen therapy patient turned on her side while in the chamber and the backrest collapsed to flat position.Patient stated that she was not hurt and chose to continue therapy.Reportedly at the end of the therapy patient stated sharp mid back and shoulder pain.Patient was treated in the department and subsequently transferred to er for review.

• Brand Name: MONOPLACE HYPERBARIC OXYGEN
• Type of Device: HYPERBARIC CHAMBER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; anaheim CA
• Manufacturer Contact: victgor arellano ; 4225 east la palma ave.; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 5409797
• MDR Text Key: 37607344
• Report Number: 2020676-2016-00002
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 21762
• Device Catalogue Number: 21762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other