FDA Adverse Event Malfunction Summary report: N

SERVO-I

MDR report key: 5430034 · Received February 11, 2016

Report

Report Number: 8010042-2016-00066
Event Type: Malfunction
Date Received: February 11, 2016
Date of Event: January 20, 2016
Report Date: January 21, 2016
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: CBK
PMA / PMN Number: K123149
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

FEB. 04, 2016 10:48 AM (GMT-5:00) ADDED BY (B)(6): FURTHER INFORMATION REGARDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

Additional Manufacturer Narrative · 1

ON (B)(6) 2016 09:19 AM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): OUR FIELD SERVICE ENGINEER(FSE) CONFIRMED THAT THE REPORTED VENTILATOR CARRIER WHEEL WAS BROKEN, AND REPLACED IT. THE VENTILATOR WAS RETURNED TO SERVICE AFTER SUCCESSFUL FUNCTIONAL TESTING. A VISUAL INSPECTION OF THE RETURNED CARRIER WHEEL CLEARLY SHOWS THAT THE PLASTIC IN THE WHEEL FORK WAS BROKEN, WHICH EXPLAINS WHY THE WHEEL FELL OFF THE CARRIER WHEN THE VENTILATOR WAS MOVED FROM ONE ROOM TO ANOTHER. THE BROKEN WHEEL FORK IMPLIES THAT IT MAY HAVE BEEN EXPOSED TO A MECHANICAL FORCE ABOVE THE DESIGNED SPECIFICATION. THE ROOT CAUSE FOR WHY THE WHEEL FORK BECAME BROKEN, HAS NOT BEEN ESTABLISHED FROM THIS INVESTIGATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT A WHEEL FELL OFF THE MOBILE CART OF THE VENTILATOR. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

Description of Event or Problem · 1

ON (B)(6) 2016 09:05 AM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
89800	SERVO-I	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	MAQUET CRITICAL CARE AB

Patients

Seq	Age	Sex	Outcome	Treatment
1