FDA Adverse Event Malfunction Summary report: N

FLOW-I C20

MDR report key: 8001198 · Received October 24, 2018

Report

Report Number: 8010042-2018-00565
Event Type: Malfunction
Date Received: October 24, 2018
Date of Event: October 9, 2018
Report Date: November 26, 2018
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: BSZ
PMA / PMN Number: K160665
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
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 PERSON: (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 PERSON: (B)(4). OUR COMPANY FIELD SERVICE ENGINEER (FSE) STATES THAT NO DEVIATIONS OR FAULTS COULD BE SEEN WHEN THE FLOW-I WAS INVESTIGATED AT THE HOSPITAL. NO PARTS WERE REPLACED. THE UNIT WAS RETURNED TO CLINICAL USE. THE EVALUATION OF THE RECEIVED DEVICE LOGS SHOW THAT SUCCESSFUL SYSTEM CHECK OUTS WERE PERFORMED PRIOR TO AND AFTER THE EVENT. THERE ARE NO INDICATIONS OF ANY MALFUNCTIONS IN THE TECHNICAL LOG. THE EVENT LOG CONFIRMS THE REPORTED ALARM FOR HIGH AIRWAY PRESSURE BUT WE HAVE NOT BEEN ABLE TO DETERMINE THE CAUSE OF THE ALARM. WE HAVE NOT BEEN ABLE TO DETERMINE THE TRUE CASE OF THE REPORTED EVENT.

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING PATIENT TREATMENT, ALARMS FOR HIGH AIRWAY PRESSURE WERE GENERATED. THERE WAS NO PATIENT HARM. (B)(4).

Description of Event or Problem · 0

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
843257	FLOW-I C20	GAS-MACHINE, ANESTHESIA	BSZ	MAQUET CRITICAL CARE AB	C20

Patients

Seq	Age	Sex	Outcome	Treatment
1