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

[425885] Per your letter dated 5/31/2005 requesting a failure 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 mewatch 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 sill 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

[15603929] The datex ohmeda anesthesia machine contains two uninterruptible power supplies (ups) for surge protection. The batteries failed in both of the ups on the anesthesia machine and shut it down. The monitoring and the machine are run from the ups. The or staff and biomed had to scramble to plug in each device into a live a/c outlet. The two ups's supplied by datex ohmeda are manufactured by oneac. Facility believes these ups units are not required on these units. They are more of a liability than an asset.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 603607
• MDR Report Key: 603607
• Date Received: 2005-05-06
• Date of Report: 2005-05-06
• Date of Event: 2005-03-23
• 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
• Returned To Mfg: 2005-03-24
• Model Number: ADU
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: R
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 593444
• Manufacturer: DATEX -OHMEDA
• Manufacturer Address: PO BOX 7550 MADISON WI 53707 US

Device Sequence Number: 2

• Brand Name: ONEAC
• Generic Name: UNINTERRUPTIBLE POWER SUPPLY, UPS
• Product Code: MPE
• Date Received: 2005-05-06
• Returned To Mfg: 2005-03-24
• 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: 593445
• Manufacturer: ONEAC
• Manufacturer Address: 29744 NORTH BRADLEY ROAD LIBERTYVILLE IL 600489700 US

Device Sequence Number: 3

• Brand Name: ONEAC
• Generic Name: UNINTERRUPTIBLE POWER SUPPLY, UPS
• Product Code: MPE
• Date Received: 2005-05-06
• Returned To Mfg: 2005-03-24
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 593446
• Manufacturer: ONEAC
• Manufacturer Address: 29744 NORTH BRADLEY ROAD LIBERTYVILLE IL 600489700 US

Patients

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