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

Model Number 3100B

Device Problem Moisture Damage (1405)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint number: (b)(4).In the event that the device becomes available for investigation or additional information becomes available 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 that he is unable to calibrate the span at zero the pressures do not come with in specification.Technical support asked if the pressure transducer had water spots on it and the customer stated there are water spots.Technical support informed the customer that there is a chance that water got into the transducer and damaged it.The part number for the pressure transducer was provided to the customer.The customer also stated that the unit was not on a patient when the problem occurred.

• Brand Name: 3100B
• 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 drive; vernon hills, IL ; 8473628056
• MDR Report Key: 5154894
• MDR Text Key: 28720045
• Report Number: 2021710-2015-01909
• 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: Hospital Service Technician
• Type of Report: Initial
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2009
• 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