ADU *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-06 for ADU * manufactured by Datex Ohmeda.

Event Text Entries

[380487] Both of the ups on the datex ohmeda adu anesthesia machine failed and shut down the machine. The batteries failed and datex ohmeda replaced both of the ups'. The ups is used for surge protection and should be removed from the units or replaced with a more satisfactory model. The 2 ups supplied by datex ohmeda are manufactured by oneac.
Patient Sequence No: 1, Text Type: D, B5

[425887] Per your letter dated 5/31/2005 requesting a faiure analysis of subject report, datex-ohmeda has received a response from oneac, the mfr of the ups unit involved in the alleged event. Their response is quoted as follows: "the ups used by datex-ohmeda does the following: 1. Is a medical grade ups offering low electrical cumulative leakage for the ups and connected equipment of less than 300 microamps 2. Provide surge protection for connected equipment 3. Battery backup in high line, low line, and no power. 4. The ups alarms when it goes to battery having received some of the upss back from the hosp and after talking to datex-ohmeda personnel, oneac believes the following occurred and would like this added to your medwatch response: 'the onm600sj-si functioned by going to battery back up under a faulty mains condition, thus keeping the attached equipment functional under these conditions. Upon depletion of the batteries, with faulty main conditions still present, the ups turned off, either due to complete loss of mains, or to protect the attached equipment from the faulty mains condition. The ups functioned properly in these actions. '"
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 603605
• MDR Report Key: 603605
• Date Received: 2005-05-06
• Date of Report: 2005-05-06
• Date of Event: 2005-05-05
• Report Date: 2005-05-06
• Date Reported to FDA: 2005-05-06
• Date Added to Maude: 2005-05-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ADU
• Generic Name: ANESTHESIA MACHINE
• Product Code: BSZ
• Date Received: 2005-05-06
• Model Number: ADU
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 593441
• Manufacturer: DATEX OHMEDA
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: ONEAC
• Generic Name: UNINTERRUPTIBLE POWER SUPPLY, UPS
• Product Code: MPE
• Date Received: 2005-05-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 593443
• Manufacturer: ONEAC
• Manufacturer Address: 27944 NORTH BRADLEY ROAD LIBERTYVILLE IL 600489700 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-05-06