FDA Adverse Event Other Summary report: N

AESPIRE

MDR report key: 1587940 · Received January 5, 2010

Report

Report Number: 2112667-2010-00001
Event Type: Other
Date Received: January 5, 2010
Date of Event: December 8, 2009
Report Date: January 5, 2010
Manufacturer: DATEX-OHMEDA
Product Code: BSZ
PMA / PMN Number: K973896
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PATIENT INFORMATION: UNDER EUROPEAN LAW AND THE (B)(6) DATA PROTECTION ACT 1998, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE REPORTED COMPLAINT WAS DUE TO A USER ERROR IN THE CONNECTION OF THE HOSES. THERE IS A STICKER ON THE FRONT OF THE ANESTHESIA MACHINE, OVER THE AUXILIARY COMMON GAS OUTLET (ACGO), ILLUSTRATING HOW TO PROPERLY CONNECT THE CIRCUIT. ADDITIONALLY, A PREOPERATIVE CHECKOUT OF THE EQUIPMENT, AS CONTAINED IN THE USER MANUAL, IS DESIGNED TO PICK UP SUCH A CONDITION.

Description of Event or Problem · 1

CUSTOMER REPORTED PT WAS CONNECTED TO THE CIRCLE BREATHING SYSTEM AND THE VENTILATOR SWITCHED ON. MACHINE REPORTEDLY ALARMED FOR HIGH PRESSURE. CLINICIAN REPORTEDLY SWITCHED TO MANUAL MODE OF VENTILATION AND DIFFICULTY WAS NOTED. IT WAS SUBSEQUENTLY NOTED THAT THE EXPIRATORY LIMB OF THE CIRCLE SYSTEM WAS INADVERTENTLY CONNECTED TO THE AUXILIARY COMMON GAS OUTLET. THE PT REPORTEDLY SUFFERED A BILATERAL TENSION PNEUMO-THORACES AND HAS MADE A FULL RECOVERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AESPIRE	ANESTHESIA MACHINE	BSZ	DATEX-OHMEDA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention