FDA Adverse Event Malfunction Summary report: N

SPACELABS ARKON ANESTHESIA WORKSTATION

MDR report key: 5007727 · Received August 17, 2015

Report

Report Number: 9611295-2015-00004
Event Type: Malfunction
Date Received: August 17, 2015
Date of Event: July 24, 2015
Report Date: September 25, 2017
Manufacturer: SPACELABS HEALTHCARE LTD.
Product Code: CBK
PMA / PMN Number: K113051
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER TURNED THE UNIT OFF AND BACK ON WHICH SUCCESSFULLY RESET THE DEVICE, THEN CONTINUED TO USE THE DEVICE THE REST OF THE DAY. SPACELABS HAS LAUNCHED AN INVESTIGATION INTO THIS EVENT AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative · 1

BASED ON THE SERVICE LOGS AND ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER, FAULTY COMMUNICATION FROM THE DU TO ACB WAS FOUND. DU PN 050-9003-00 WAS REPLACED AND THE REPAIRED UNIT PASSED ALL FUNCTIONAL TESTS. THE REPAIRED UNIT WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. DURING THE DU COMMUNICATION ISSUE CLINICAL STAFF RESPONDED APPROPRIATELY PER THEIR TRAINING; MANUAL VENTILATION, MEDICAL GASES AND ALARMS REMAINED OPERATIONAL. THIS INVESTIGATION IS CONSIDERED COMPLETE AND THIS PARTICULAR ISSUE CLOSED.

Additional Manufacturer Narrative · 1

THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER MEDICAL DEVICE EVALUATION RESULTS CODE.

Description of Event or Problem · 1

SPACELABS RECEIVED A REPORT THAT AN ARKON ANESTHESIA MACHINE ENTERED A FAILED STATE DISPLAYING THE TRIANGLE WARNING ICON DURING A SURGICAL CASE ON (B)(6) 2015. NO INJURY WAS REPORTED AS THE RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
543178	SPACELABS ARKON ANESTHESIA WORKSTATION	ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR	CBK	SPACELABS HEALTHCARE LTD.	99999

Patients

Seq	Age	Sex	Outcome	Treatment
1