FDA Adverse Event Malfunction Summary report: N

FLOW-I C30

MDR report key: 8178763 · Received December 19, 2018

Report

Report Number: 8010042-2018-00682
Event Type: Malfunction
Date Received: December 19, 2018
Date of Event: December 1, 2018
Report Date: December 19, 2018
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: BSZ
PMA / PMN Number: K160665
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

ACCORDING TO RECEIVED INFORMATION FROM OUR FIELD SERVICE ENGINEER, THE PERSONNEL HAD FORGOT TO SECURE THE PATIENT CASSETTE BY SETTING THE PATIENT CASSETTE LOCKING MECHANISM IN LOCKED POSITION PRIOR TO USE. THIS RESULTED IN THE PATIENT CASSETTE BECOMING SLIGHTLY DISLODGED FROM THE ORIGINAL POSITION WHEN CHANGING THE CO2 ABSORBER DURING ONGOING SURGERY AND THUS CREATING A LEAKAGE. NO PARTS NEEDED TO BE REPLACED. THERE ARE NO DEVICE LOGS AVAILABLE TO CONFIRM THE REPORTED EVENT. OUR CONCLUSION IS THAT THE EVENT WAS CAUSED BY THE USER NOT SECURING THE PATIENT CASSETTE PROPERLY, I.E. USER ERROR. THE LEAKAGE IS DETECTED BY THE SYSTEM AND ALARMS TO ALERT THE USER ARE GENERATED. 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).

Description of Event or Problem · 0

IT WAS REPORTED THAT DURING PATIENT TREATMENT, WHEN THE CO2 ABSORBER WAS CHANGED, THE PATIENT CASSETTE BECAME SLIGHTLY DISLODGED FROM ITS ORIGINAL POSITION AND THUS CAUSING A LEAKAGE. THERE WAS NO PATIENT HARM REPORTED. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1017145	FLOW-I C30	GAS-MACHINE, ANESTHESIA	BSZ	MAQUET CRITICAL CARE AB	C30

Patients

Seq	Age	Sex	Outcome	Treatment
1