MAUDE Adverse Event Report: CAREFUSION CORPORATION VITAL SIGNS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 5503EU

Device Problem Device Inoperable (1663)

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

Event Date 03/20/2017

Event Type  malfunction  

Event Description

Anesthesia md was effectively bagging patient with mapleson while transferring patient from induction room to mri suite when the mapleson stopped working.The bag /valve would not work (blow up the bag) and could not get a breath to the patient.After a few failed attempts, anesthesia md was able to get a few breaths in with 'plugging' the blue valve with her finger while the ga nurse ran to get a new mapleson.Pt remained stable and mri was completed as scheduled.

• Brand Name: VITAL SIGNS
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): CAREFUSION CORPORATION; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 6544476
• MDR Text Key: 74439624
• Report Number: 6544476
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/25/2017,04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5503EU
• Device Catalogue Number: 5503EU
• Device Lot Number: 0001044498
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 28