MAUDE Adverse Event Report: GALEMED CORP.; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Event Description

3 babi-plus bubble continuous positive airway pressure (cpap) equipment in the neonatal intensive care unit (nicu) were found to have missing peep valve.These were new products and had never been used on the patient.The peep valves are critical to delivering appropriate peep to our babies in the nicu.Staff reached out to sovereign medical representative to seek replacement.

• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): GALEMED CORP.; 17574 via cuatro camino; rancho santa fe CA 92067
• MDR Report Key: 9495583
• MDR Text Key: 172019091
• Report Number: 9495583
• 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
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1