MAUDE Adverse Event Report: CAREFUSION SENSOR MEDICS; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

The following descriptions of the event were copied from a carefusion ventilation complaint form submitted on behalf of the user facility by the distributor in (b)(4)."unit was running on patient and the user (name removed) moved the ventilator a little bit towards the patient in order to decrease the distance between patient and hfov.Suddenly the vent switched off without any visual or audible indication (no led, no alarm).The user though he probably touched the main switch but it was still on "on" position.(name removed) than took care of the patient and changed to manual ventilation (bag).The "battery low" indicator is off but it can be activated by pushing the reset knob (no problem with the battery or "battery low" led itself) this is a short description about the outage of hfov 3100a, sn: (b)(4).A (b)(6) male patient, who was being treated by me, was being ventilated with the above mentioned ventilator.On (b)(6) at 8:00am, the ventilator shopped working during basic nursing care.There was no alarm, all indicators had gone out and the unit didn't work anymore.The patient was ventilated sufficiently and immediately with an ambu bag.The informed medical engineer, (name removed) started the ventilator again.After a short period of time the unit failed again.We have changed the location (positioning within the icu) of the unit and after a restart and very detailed inspection the vent was working without any problem until the patient was transferred the next day".

Manufacturer Narrative

(b)(4).Carefusion is in the process of making arrangements with the foreign user facility and foreign distributor to have the device returned to the carefusion european service ctr for evaluation and repair.Once the evaluation and repair of the device is complete, carefusion will submit a f/u medwatch report.

• Brand Name: SENSOR MEDICS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer Contact: james stytle ; 1100 bird center dr.; palm springs, CA 92262 ; 7608837120
• MDR Report Key: 4568380
• MDR Text Key: 5547827
• Report Number: 2021710-2015-00405
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• 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: 768910
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/22/2015
• Device Age: 17 YR
• Event Location: Hospital
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/1997
• 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
• Treatment: PRINTORNOX,; HUMIDIFIER,
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 7