MAUDE Adverse Event Report: CAREFUSION STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH; SOMNOSTAR & SERIES SLEEP SYSTEM

Model Number 41 SOMNOSTAR Z4 V9

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer provided carefusion with the suspect device.Visual examination of the somnostar z4 amplifier showed it to be in good condition with no noticeable damage.Carefusion conducted a simulated sleep study test for the somnostar z4 amplifier with known good calibrated equipment in place.The somnostar software had no issue with recognizing the suspect amplifier.Once the somnostar z4 amplifier was connected to the test equipment, signal calibration was achieved and performed the impedance checks (ics) at beginning of the diagnostics test.Impedance check (ics) was satisfactory.Carefusion performed simulated sleep study for a total of (b)(4) epochs.During testing, all sine wave signals were present and clean.Spo2 readings were obtainable.The amplifier was left powered on for two hours.The temperature of the amplifier was warm to the touch in comparison to other amplifiers but not extremely hot as stated by the customer.A definitive root cause of the event could not be determined with the available information.Carefusion continues to track and trend any incident related to this issue.(b )(4).

Event Description

The customer reported that the 41 somnostar z4 amplifier was getting extremely hot on the bottom.The customer moved the amplifier to another room and tested it; however, the reported issue still persisted.The amplifier was not being recognized in the hardware configuration screen.The customer attempted various methods of troubleshooting with no success.The device was on the patient at the time of the event; however, there was no patient consequence.The suspect device was sent to carefusion for analysis.

• Brand Name: STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH
• Type of Device: SOMNOSTAR & SERIES SLEEP SYSTEM
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): DUCOMMUN LA BARGE; 2222 east pensar drive; appleton WI 54911 8789
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5166860
• MDR Text Key: 29216647
• Report Number: 2021710-2015-01960
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41 SOMNOSTAR Z4 V9
• Device Catalogue Number: 16846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2008
• 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