MAUDE Adverse Event Report: PHILIPS ANESTHESIA CARE BSZ; DAMECA, GAS-MACHINE, ANESTHESIA

Model Number 866205

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The users reported that internal oxygen tube came off at the manometer side of the anesthesia system.This caused a huge bang and leaking o2.There have been no devices delivered to any customers in the u.S.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

• Brand Name: BSZ
• Type of Device: DAMECA, GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): PHILIPS ANESTHESIA CARE; islevdalvej 211; roedovre, region hovestaden 2610 ; DA 2610
• Manufacturer Contact: phyllis mccarthy ; 2000 minuteman road; andover, MD 01810 ; 9786592811
• MDR Report Key: 3823834
• MDR Text Key: 20972752
• Report Number: 3010587095-2014-00010
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1