N/A M1091335VSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752135680), received between Dec 28, 2022 and Mar 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K093913); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2024Material Integrity Problem; Material Integrity Problem

  PEEP VALVE FAULTY. 3 CIRCUITS USED ON 2 DIFFERENT PANDA RESUSCITATORS WOULD ONLY PROVIDE 3 CMH2O OF PEEP DESPITE TURNING VALVE HIGHER AND HIGHER.  RECEIVED MEDWATCH REPORT 0700220000-2023-8422.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965564 ↗
• MalfunctionDec 28, 2022Pressure Problem

  FOLLOWING PATIENT DELIVERY, TEAM ATTEMPTING TO GIVE PATIENT POSITIVE END-EXPIRATORY PRESSURE (PEEP) THROUGH T-PIECE RESUSCITATOR IN NEO ROOM. PER REPORT, PROVIDER UNABLE TO ACHIEVE PEEP GREATER THAN 7 AND HAD INSTANCES OF LOSING PEEP DURING PATIENT CARE. OF NOTE - THIS HAS BEEN REPORTEDLY HAPPENING WITH THIS PRODUCT RECENTLY AND CNS (REPORTER) IS WORKING WITH PRODUCT REP. AND SUPPLY CHAIN TO INVESTIGATE POTENTIAL PRODUCT CHANGE OR DEFECTS AFFECTING USE OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060740 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093913. One submission often covers many models, so check the product and lot details in each record.

• Z-0821-2025 · Dec 10, 2024 · Open, Classified
  Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
• Z-0004-2025 · Aug 30, 2024 · Open, Classified
  Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
• Z-0639-2016 · Oct 22, 2015 · Terminated
  Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory