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

Model Number 3100A

Device Problem Moisture Damage (1405)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In the event the device becomes available for evaluation or additional information becomes available this information will be provided in a follow-up report.(b)(4).At this time, carefusion has not received the device from the customer.

Event Description

The customer claims he is not able to calibrate the span at the high end; the pressures do not come within the specification.Technical support asked if the pressure transducer line had water spots on it, he claims there are water spots, informed customer that there is a chance that water got to the transducer and damage it.The part number for the pressure transducer was provided.The customer stated that this unit was not on a patient when the problem occurred.

• 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 drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5156891
• MDR Text Key: 28752011
• Report Number: 2021710-2015-01913
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/22/2015

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: Biomedical Engineer
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• 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: Unknown
• Patient Sequence Number: 1