FDA Adverse Event Malfunction Summary report: N

PERRY

MDR report key: 23728616 · Received December 5, 2025

Report

Report Number
23728616
Event Type
Malfunction
Date Received
December 5, 2025
Date of Event
May 19, 2025
Report Date
September 30, 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 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 THE GAS LINES MAY HAVE BEEN PUT IN BACKWARDS. AFTER PERFORMING SOME CHAMBER PRESSURIZATIONS, THE UNIT DIRECTOR ASKED A MAINTENANCE STAFF TO REMOVE THE FRONT PANEL OF THE GAS EXCHANGE BOX FOR THE CHAMBER 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 ANY PATIENTS TREATED IN THAT CHAMBER [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, UNKNOWN (PER SITE REPORTER). PERRY SENT A TECHNICIAN ON [DATE REDACTED] TO ASSESS AND FIX THE PROBLEM. PERRY CORRECTED THE ERROR MADE DURING THEIR INSTALLATION OF THE GAS EXCHANGE PANELS AND GAS LINES. THE TECHNICIAN ALSO REPLACED THE CHECK VALVES ON THE CHAMBER DOORS FOR THE AIR BRAKE EQUIPMENT. HE CHECKED AND ASSESSED BOTH CHAMBERS AND THEY WERE BOTH FUNCTIONING PROPERLY. THE UNIT LEADERSHIP LABELED THE GAS EXCHANGE PANELS TO SAY "CHAMBER GAS" AS THE MANIFOLD PANEL BOX ONLY CONTROLS THE TYPE OF GAS ENTERING THE CHAMBERS. THE PERRY TECHNICIAN ALSO SHOWED UNIT STAFF A NEW WAY TO CHECK CHAMBER GAS FLOW TO THE CHAMBER AND THE UNIT IS ADDING THIS INTO THEIR WEEKLY SAFETY CHECKS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2783923 PERRY CHAMBER, HYPERBARIC CBF PERRY BAROMEDICAL CORPORATION UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 65 YR Female