MAUDE Adverse Event Report: OMNI ICART

Model Number 31113.801

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Facility notified (b)(4) sales rep that there was a burning smell coming from one of the rooms at the hosp.A black "goo" was found under the cart in question that appears to be melted plastic.Cart was not being used during a procedure at the time smell was noticed, however, cart was plugged into wall.No injuries to a pt or staff member was reported.Facility: (b)(6).Device in question is "drop shipped," meaning it is delivered from the manufacturer to the customer without stopping at the importer facility (b)(4) for any testing, inspection or re-labeling.

Manufacturer Narrative

An investigation will not be performed by (b)(4) as device in question is manufactured by omni corporation.Device in question currently remains at user facility.(b)(4) considers this matter closed.However, in the event we receive add'l info, (b)(4) will provide manufacturer (omni) of the info.

• Brand Name: ICART
• Type of Device: CART
• Manufacturer (Section D): OMNI; detroit MI
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: 353 corporate woods pkwy.; vernon hills, IL 60061
• MDR Report Key: 4353281
• MDR Text Key: 5145665
• Report Number: 1418479-2014-00055
• Device Sequence Number: 1
• Product Code: FWZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/15/2014,12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 31113.801
• Device Catalogue Number: 31113.801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2014
• Distributor Facility Aware Date: 12/01/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1