Curaplex MRIPEEP-ARecalls & reported problems

Bound Tree Medical, LLC · PEEP VALVE,19MM,MRI,30MM ADAPTER 20/ CA · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810071637278), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Integrity Problem1

Patient problems

Low Oxygen Saturation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 14, 2023Material Integrity Problem; Material Integrity Problem
UPON DISCONNECTING PT FROM VENT AND MANUALLY BAGGING TO ICU. WITHIN FIRST COUPLE BREATHS MANUALLY DELIVERED, NOTICED PEEP VALVE WAS NOT MAKING STANDARD NOISE. UPON FURTHER ASSESSMENT NOTICE PTS CHEST KEPT RISING BUT NOT FALLING. QUICKLY DISCONNECTED FROM ET TUBE AND NOTED A HUGE RUSH OF AIR RELEASED FROM ET TUBE. ONE MORE TIME I RECONNECTED BAG AND DELIVERED TWO MORE BREATHS NOTING AGAIN NO TRUE EXHALE FROM PT/BAG. DISCONNECTED AGAIN AND RUSH OF AIR NOTED AGAIN. QUICKLY HAD PT RETURNED TO ROOM AND PLACED BACK ON VENT. ACQUIRED NEW AMBU BAG AND PEEP VALVE. NEW EQUIPMENT WORKED PROPERLY AND PT WAS SAFELY DELIVERED TO NEW UNIT.
Patient problems: Low Oxygen Saturation
MAUDE report 18326718 ↗

Device details

UDI-DI	`00810071637278`
Brand	Curaplex
Model	MRIPEEP-A
Catalog no.	301-MRIPEEP-A
Company	Bound Tree Medical, LLC
Product code	BYE · Attachment, breathing, positive end expiratory pressure
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 9, 2023

Device type (GMDN): PEEP valve, single-use

A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.