MAUDE Adverse Event Report: NEOFORCE INC. NEOPIP NEONATAL T-PIECE CIRCUIT W/PEEP; ATTACHMENT, BREATHING, PEEP

Model Number NF-150

Device Problems Gradient Increase (1270); Activation, Positioning or Separation Problem (2906); Pressure Problem (3012)

Patient Problems Pneumothorax (2012); Respiratory Distress Syndrome of Newborns (2046)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

Hospital had 2 lots of inventory lot #'s 1140919005 and 1150430061.Devices from each lot were pulled from inventory and tested to attempt to replicate the failure mode.Simulated handling and moving circuit on bed surface according to customer complaint to see if high pressures are generated by the peep valve at the flow conditions and adjusting flow rate during use (contraindicated) we could not replicate device failure mode.Tested devices met specification and did not exceed pressure limits.(b)(4).

Event Description

Hospital reported that while using a neopuff (fisher and paykel) infant resuscitator in conjunction with our neopip t-piece circuit (neoforce inc.) that "there was a recent event during a preemie resuscitation where it was noted that all of a sudden a very high level of peep was being delivered (inadvertently) which resulted in a pneumothorax needing needle decompression in the dr (delivery room).Further: "in this particular incident the circuit had changed hands several times from the therapist to the nurse to the doctor back to the therapist so it could have been bumped in transition." hospital says it has happened before but not to this degree and they felt that the circuit can be adjusted too easily.

• Brand Name: NEOPIP NEONATAL T-PIECE CIRCUIT W/PEEP
• Type of Device: ATTACHMENT, BREATHING, PEEP
• Manufacturer (Section D): NEOFORCE INC.; 35 commerce dr.; ivyland PA 18974
• Manufacturer Contact: otho boone ; 35 commerce dr.; ivyland, PA 18974 ; 2156726800
• MDR Report Key: 5313421
• MDR Text Key: 34071143
• Report Number: 3005599562-2015-00001
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: NF-150
• Device Lot Number: 1140919005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 2