Bio-Med Devices, Inc. CROSSVENT (REF 2200IC)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813841020805), received between Jun 6, 2016 and May 27, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER NARRATIVE: "THIS VENT IS USED ON OUR TRANSPORT STRETCHER. A THERAPIST WENT TO PICK UP AN INTUBATED BABY. WHILE HE WAS IN THE REFERRING HOSPITAL, HE PLACED THE BABY ON THE CROSSVENT WITH THE AIR AND OXYGEN HOOKED TO THE WALL. BABY WAS FINE. HE SWAPPED GASES TO THE TANKS AND TOOK THE BABY TO THE AMBULANCE. ONCE HE GOT ON THE AMBULANCE THE BABY BEGAN TO DESAT, CHEST MOVEMENT DECREASED, AND POOR BREATH SOUNDS NOTED. HE HAD TO GASES HOOKED TO THE WALL OUTLET OF THE AMBULANCE. BOTH CYLINDERS ON THE AMBULANCE WERE FULL. ET TUBE WAS CONFIRMED IN PLACE. THEY TOOK THE BABY OFF THE VENT AND BAGGED. THE SATS CAME UP AND THE BREATH SOUNDS WERE GOOD. HE PUT THE BABY BACK ON THE VENT AND WITHIN A COUPLE OF MINS THE SAME SCENARIO HAPPENED, DESAT, POOR BREATH SOUNDS AND DECREASED CHEST MOVEMENT. HE ENDED UP BAGGING THE BABY FOR THE REMAINDER OF THE TRANSPORT. HE SAID THE VENT WAS SHOWING THE SET PIP AND PEEP. NOTHING LOOKED OFF ON THE VENT SCREEN. ONCE HE GOT BACK, WE LEFT THE CIRCUIT ON AND TRIED TO TROUBLESHOOT. WE PLACED A TEST LUNG AND STARTED THE VENT. NOTHING LOOKED OUT OF PLACE. THE TEST LUNG HELD THE PEEP AND IT WAS NOTICEABLE WHEN A BREATH WAS DELIVERED. YOU COULD TAKE THE TEST LUNG O

  Patient problems: Respiratory Insufficiency

  MAUDE report 22088473 ↗
• MalfunctionAug 3, 2023Premature Discharge of Battery; Premature Discharge of Battery

  UNIT STOPPED VENTILATING, WITH ALARMS, WHILE ON PATIENT. NO PATIENT INJURY. ASSUMEDLY, BACKUP VENTILATION WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452209 ↗
• MalfunctionApr 7, 2018Device Inoperable

  TRANSPORT VENTILATOR "IS SAID TO HAVE STOPPED WORKING DURING PATIENT TRANSPORT." STILL TRYING TO OBTAIN INCIDENT DETAILS. NOT CLEAR YET IF THE VENTILATOR WAS ACTUALLY APPLIED TO A PATIENT AT THE TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7405605 ↗
• MalfunctionJun 6, 2016Pressure Problem

  NARRATION FROM USER OF TRANSPORT VENTILATOR: AFTER 20 MINUTES ON A TRANSPORT VENTILATOR, 'PATIENT O2 SATS DROPPED. COULD NOT DIAL IN A PIP OR PEEP PRESSURE. COULD NOT HEAR THE VENT CYCLING.' PATIENT WAS THEN HAND-VENTILATED INSTEAD, AND THERE WAS NO INJURY TO THE PATIENT. VENTILATOR WAS REMOVED FROM SERVICE, AND HOSPITAL TECHNICIANS COULD FIND NOTHING WRONG. TECHNICIANS DID NOTICE THAT ONE OF THE SUPPLY OXYGEN TANKS TAKEN ON THE TRANSPORT WAS EMPTY. IT WAS SUSPECTED THAT RUNNING OUT OF PRESSURIZED SUPPLY GAS MAY HAVE CAUSED THIS INCIDENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 5701969 ↗
• Jun 6, 2016Loss of Power; Device Displays Incorrect Message; Device Operates Differently Than Expected

  TRANSPORT VENTILATOR "TURNS OFF WHILE ON PATIENTS" WITH ALARMS SOUNDING. NO DETAILS ON ANY SPECIFIC INCIDENTS PROVIDED BY USER, AND THERE WERE NO PATIENT INJURIES. DEVICE WAS RUN ON BATTERY POWER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5701319 ↗