MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Connection Problem (2900)

Patient Problems Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Part/lot number are unknown.The faulty cap/diaphragms are not available for investigation as they have been disposed.

Event Description

The following reported event occurred in the (b)(6), complaint form details: "over the weekend we had a serious incident involving the cap/diaphragm sets lot nos 0000538059.The oscillator stopped working and the cap was found to be faulty, the replacements were also faulty.The equipment was then changed.This meant a very sick baby had to be manually bagged for nearly an hour whilst the nursing/medical staff resolved the issue - a far from ideal situation.Understandably the staff involved were more concerned with the baby than keeping disposable items.To confirm we never reuse the caps".

• Brand Name: HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 7149227830
• MDR Report Key: 5426464
• MDR Text Key: 37902310
• Report Number: 2021710-2016-03090
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2013
• Initial Date FDA Received: 02/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention