FDA Adverse Event Malfunction Summary report: N

SERVO-I

MDR report key: 8343394 · Received February 15, 2019

Report

Report Number: 8010042-2019-00092
Event Type: Malfunction
Date Received: February 15, 2019
Date of Event: January 17, 2019
Report Date: June 25, 2019
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: CBK
PMA / PMN Number: K123149
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL
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 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

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). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE NOZZLE UNITS IN THE O2 AND AIR GAS MODULE WAS REPLACED FOR PROACTIVE MEASURES. EVALUATIONS OF THE RECEIVED DEVICE LOGS SHOW MATCHING EVENTS, BETWEEN JANUARY 17, AT 01:14 TO JANUARY 19 20:54, SEVERAL ALARMS FOR HIGH O2 CONCENTRATION WERE GENERATED. A PRE-USE CHECK WAS CONFIRMED TO BE SUCCESSFUL PRIOR TO THIS VENTILATION PERIOD. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION. PATIENT INVOLVEMENT IS UNKNOWN. (B)(4).

Description of Event or Problem · 0

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

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
135349	SERVO-I	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	MAQUET CRITICAL CARE AB

Patients

Seq	Age	Sex	Outcome	Treatment
1