MAUDE Adverse Event Report: GE HEALTHCARE T-PIECE NEONATAL PATIENT CIRCUIT KIT; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Catalog Number M1091335VS

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

T-piece neonatal patient circuit kit, disposable, lot# 23207 manufacture date [redacted date] peep valve faulty.3 circuits used on 2 different panda resuscitators would only provide 3 cmh2o of peep despite turning valve higher and higher.Tested off patient and found that when turned as high as the peep will go peep jumped from 3-10 cmh2o.Saved circuits and package.

• Brand Name: T-PIECE NEONATAL PATIENT CIRCUIT KIT
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): GE HEALTHCARE; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 18551664
• MDR Text Key: 333343973
• Report Number: 18551664
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: M1091335VS
• Device Lot Number: 23207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1