FDA Adverse Event Malfunction Summary report: N

SERVO-U

MDR report key: 7556893 · Received May 31, 2018

Report

Report Number: 8010042-2018-00271
Event Type: Malfunction
Date Received: May 31, 2018
Date of Event: May 7, 2018
Report Date: June 27, 2018
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: CBK
PMA / PMN Number: K151814
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 PERSON: (B)(4).

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN CONNECTED TO A PATIENT, THE VENTILATOR ALARMED FOR HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE). THERE WAS NO PATIENT HARM. (B)(4).

Additional Manufacturer Narrative · 1

THE VENTILATOR WAS EXAMINED BY THE HOSPITAL BIOMED AND THERE WAS NO RECURRENCE OF THE REPORTED ISSUE. NO INFORMATION HAS BEEN RECEIVED REGARDING ANY PARTS REPLACEMENT. NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE HOSPITAL AND NO VENTILATOR LOGS WERE PROVIDED. THE VENTILATOR HAS BEEN RETURNED FOR CLINICAL USE. A HIGH PEEP ALARM WILL OCCUR WHEN THE MEASURED END EXPIRATORY PRESSURE IS ABOVE THE PRESET ALARM LIMIT FOR THREE CONSECUTIVE BREATHS. THE FIRST REMEDY ACTION ACCORDING TO THE USER'S MANUAL IS TO CHECK THE PATIENT'S BREATHING SYSTEM AND THEREAFTER THE VENTILATOR SETTINGS. DUE TO THE LIMITED INFORMATION PROVIDED, NO INVESTIGATION HAS BEEN POSSIBLE, THEREFORE THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

Description of Event or Problem · 1

(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
398397	SERVO-U	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	MAQUET CRITICAL CARE AB

Patients

Seq	Age	Sex	Outcome	Treatment
1