FDA Adverse Event Malfunction Summary report: N

SERVO-S

MDR report key: 8110671 · Received November 28, 2018

Report

Report Number: 8010042-2018-00637
Event Type: Malfunction
Date Received: November 28, 2018
Date of Event: June 5, 2018
Report Date: January 25, 2019
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: CBK
PMA / PMN Number: K123149
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERON: (B)(4). OUR FSE WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. WE HAVE BEEN PROVIDED EXCERPT LOGS FROM THE FSE. THE LOGS CONFIRM THE REPORTED TECHNICAL ALARMS. THE REMEDY FOR THE ALARMS IN THE SERVICE MANUAL IS, TO REPLACE THE CONTROL CIRCUIT BOARD. THE FSE DID THE REPLACEMENT. THE CONTROL CIRCUIT BOARD WAS RETURNED FOR OUR INVESTIGATION. THE REPORTED ISSUE COULD NOT BE REPRODUCED BY US THEREFORE THE ROOT CAUSE COULD NOT BE IDENTIFIED.

Additional Manufacturer Narrative · 0

GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

Description of Event or Problem · 0

MANUFACTURER REF. #: (B)(4).

Description of Event or Problem · 0

IT WAS REPORTED THAT THE VENTILATOR GENERATED THREE TECHNICAL ERROR CODES INDICATING COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
949119	SERVO-S	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	MAQUET CRITICAL CARE AB

Patients

Seq	Age	Sex	Outcome	Treatment
1