MAUDE Adverse Event Report: CAREFUSION 3100A; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Low Readings (2460); Improper Flow or Infusion (2954); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

Carefusion complaint number: (b)(4).The customer did not provide patient demographics such as age, date of birth, gender, and weight.In the event the device is received for evaluation or additional information is provided a follow-up report will be submitted.(b)(4).At this time, carefusion has not received the device from the customer.

Event Description

The customer stated "this unit was making strange sounds and the map will not go past 12 cm while on a patient, the patient was removed from this oscillator and placed on another oscillator, no harm done to the patient.".

Manufacturer Narrative

The field service representative evaluated the unit and found the ventilator to be missing hoses.Direct air and o2 was run to the vent from the wall and performance checks were done and the unit passed.The unit was run for over two hours without issue.The error was a possible user error due to the twist posts to the bellows not being locked down.The customer stated they will find their hoses and hook up the vent.

• Brand Name: 3100A
• 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 ; 75 n. fairway dr.; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5157635
• MDR Text Key: 28554708
• Report Number: 2021710-2015-01916
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention