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

Model Number 3100B

Device Problems Device Alarm System (1012); False Alarm (1013)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Carefusion complaint number: (b)(4).In the event the unit becomes available for evaluation or additional information is received a follow-up report will be submitted.(b)(4).At this time, carefusion has not received the device for evaluation.

Event Description

The customer called and said "this unit will not stop alarming.When he turns the unit off it keeps alarming even after hitting the reset to stop the alarm.He unplugged the unit but it continued to alarm.Technical support advised him take out the 9 volt battery in the back and the alarm finally stopped.The customer stated that this issue occured during calibration and that there was no patient involvement.

Manufacturer Narrative

Results of investigation: the field service representative evaluated the unit and replaced the alarm printed circuit board and the pressure transducer assembly.In the event the boards are returned for evaluation a follow-up report will be submitted at that time.

• 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 60061 ; 8473628056
• MDR Report Key: 5154843
• MDR Text Key: 28720577
• Report Number: 2021710-2015-01900
• 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
• Type of Report: Followup
• Report Date: 09/21/2015

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: No Information
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2003
• 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