MAUDE Adverse Event Report: FISHER AND PAYKEL HEALTHCARE CPAP NASAL TUBING 70MM

Catalog Number BC191

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/10/2017

Event Type  malfunction  

Event Description

Pedi patient with grade iii ivh ventriculomegaly was receiving routine icu care involving cpap device.Rn noticed cpap prongs popped off tubing 5 times during shift, o2 sat found to be less than 90 during these episodes.Dates of use: (b)(6) 2017.Diagnosis or reason for use: respiratory dysfunction.

• Brand Name: CPAP NASAL TUBING 70MM
• Type of Device: CPAP NASAL TUBING 70MM
• Manufacturer (Section D): FISHER AND PAYKEL HEALTHCARE
• MDR Report Key: 6427372
• MDR Text Key: 70752886
• Report Number: MW5068593
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2016
• Device Catalogue Number: BC191
• Device Lot Number: 2100085377
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Weight: 6