FDA Adverse Event Malfunction Summary report: N

PERRY

MDR report key: 23728562 · Received December 5, 2025

Report

Report Number
23728562
Event Type
Malfunction
Date Received
December 5, 2025
Date of Event
May 21, 2025
Report Date
September 25, 2025
Manufacturer
PERRY BAROMEDICAL CORPORATION
Product Code
CBF
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MD
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

DURING TREATMENT, THE HBOT [HYPERBARIC OXYGEN THERAPY] CHRN [CERTIFIED HYPERBARIC REGISTERED NURSE] WAS NOT ABLE TO GET THE CHAMBER TO PRESSURIZE, THE AIR ALARM PANEL IN THE HBOT ROOM ALARMED, AND PATIENT TREATMENT WAS ABORTED. CHRN NOTIFIED THE SAFETY DIRECTOR, THE UNIT DIRECTOR, AND THE MEDICAL DIRECTOR WAS PRESENT IN THE CHAMBER ROOM DURING THE EVENT. NO HARM NOTED TO THE PATIENT. SAFETY DIRECTOR CALLED FACILITIES AND CLINICAL ENGINEERING AS SOON AS SHE WAS CALLED ABOUT THE PROBLEM. FACILITIES SENT THE MAINTENANCE TEAM UP TO LOOK AND EXCHANGE THE MEDICAL AIR AND TO CHECK THE TANKS. FACILITIES REPORTED SEVERAL OF THE AIR TANKS WERE EMPTY, EVEN THOUGH THEY WERE JUST CHANGED ON [DATE REDACTED]. ON [DATE REDACTED], PERRY REPLACED THE OLD GAS EXCHANGE PANELS WITH NEW PERRY MODELS. THE UNIT DIRECTOR HAD IMMEDIATE CONCERNS THAT THE GAS LINES MAY HAVE BEEN PUT IN BACKWARDS. AFTER PERFORMING SOME CHAMBER PRESSURIZATIONS, THE UNIT DIRECTOR ASKED THE MAINTENANCE STAFF TO REMOVE THE FRONT PANEL OF THE GAS EXCHANGE BOX FOR CHAMBER 2 AND IT WAS IDENTIFIED THAT PERRY DID PUT THE LINES IN BACKWARDS, THE AIRLINE WAS ATTACHED TO THE OXYGEN, AND THE OXYGEN WAS ATTACHED TO THE AIR. THIS MEANT THAT PATIENTS TREATED [DATES REDACTED] WERE PRESSURIZED ON AIR INSTEAD OF OXYGEN, THUS NOT RECEIVING THE CORRECT TREATMENT. CLINICAL ENGINEERING WAS MADE AWARE AND CALLED AND SPOKE TO PERRY. MANUFACTURER RESPONSE FOR HYPERBARIC CHAMBER, PERRY (PER SITE REPORTER). PERRY SENT A TECHNICIAN ON [DATE REDACTED] TO ASSESS THE EQUIPMENT AND CORRECT THE ERROR THAT WAS MADE WITH THE GAS LINES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1913115 PERRY CHAMBER, HYPERBARIC CBF PERRY BAROMEDICAL CORPORATION UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 62 YR Female