SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3200/R
Received Nov 13, 2023 · Event occurred Oct 17, 2023
Report 2020676-2023-00020 · MDR key 18127540
Device
Generic name
Chamber, Hyperbaric
Manufacturer
Sechrist Industries Inc.Model number
3200/RCatalog number
3200/R
Product problems
- Key or Button Unresponsive/not Working
- Key or Button Unresponsive/not Working
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTED THAT THE EMERGENCY VENTILATION BUTTON WAS NOT WORKING PROPERLY. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS BASED SOLELY ON THE CUSTOMER'S REPORTED ISSUE. THE DEVICE IS NOT IN USE AT THIS TIME AND IS PENDING REPAIR SERVICES. THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).
Description of Event or Problem
CUSTOMER REPORTING THE EMERGENCY VENTILATION BUTTON IS NOT WORKING PROPERLY. NO PATIENT INJURY WAS REPORTED.