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

Model Number 3100B

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 11/25/2013

Event Type  malfunction  

Manufacturer Narrative

This initial report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.(b)(4) the carefusion tech support specialist in conjunction with the customer determined that the root cause of the reported event was faulty cap/diaphragms.The carefusion failure analysis lab tech evaluated the cap/diaphragms and verified the complaint.This is a known issue for cap/diaphragms manufactured prior to may 28, 2013 that has already been addressed with an internal action.

Event Description

The following reported event which occurred in the (b)(6) received by carefusion; complaint form details: "after the 3100b oscillator s/n.(b)(4) had been used successfully on the (b)(6) 2013 on a patient the staff were setting the circuit up for the next possible patient.They were unable to get a high enough pressure for paw during the pre-use checks.The maximum they got was 11 cmh2o.When the hospital technicians checked the unit they got 19 cmh2o.When i attended on (b)(6) 2013 i pressurized the circuit up to 40 cmh2o; i couldn't replicate the fault.Medical staff are very aware of how to set up the oscillator and find leaks.I did however notice that on 2 of the cap diaphragms tried out, the base and the top appeared loose.When disassembled and re-assembled these 2 cap diaphragms they did not appear to click back into place securely.As there was no packaging for these 2 caps we are unsure of the lot nos.The intensive care unit also had 1 box of p/no.766896 lot no.0000323004 and 1 opened paket which contained no caps of lot no.Y08p2256.They also had 2 complete circuits in stock p/no.11744-730k both lot nos.0000503755.Both these circuits contained cap diaphragms lot nos.2288523.The fault appears to have been intermittent possibly depending which caps were used.

• 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: 5428014
• MDR Text Key: 38540418
• Report Number: 2021710-2016-03096
• 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: 11/26/2013

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: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770881-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2013
• Initial Date FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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