MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; AIRWAY ADAPTOR, NASAL CANNULA

Model Number M2773A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Distress (2329)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that, a patient was due to be extubated, and when attempting to suction the et tube prior to extubating, the staff was unable to do so as the adapter was stuck.According to the customer, in their efforts to remove it, the patient became very distressed and the tube was pulled out.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PHILIPS
• Type of Device: AIRWAY ADAPTOR, NASAL CANNULA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8398856
• MDR Text Key: 138365572
• Report Number: 9610816-2019-00063
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K060221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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
• Device Model Number: M2773A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 5