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 11/11/2014

Event Type  malfunction  

Event Description

Facility notified richard wolf medical instrument corporation (rwmic) sales representative that there was a burning smell coming from one of the rooms at the hospital.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 patient 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 (rwmic) for any testing, inspection or re-labeling.

Manufacturer Narrative

An investigation will not be performed by rwmic as device in questioned is manufactured by (b)(4) corporation.Device received at rwmic on 11/13/2014 and will be forwarded to (b)(4) for investigation.A request for additional info has been submitted to facility, no response as of 11/24/2014.Richard wolf medical instruments corporation considers this matter closed.However, in the event we received additional info, we will provide manufacturer with follow-up info.

• Brand Name: ICART
• Type of Device: CART
• Manufacturer (Section D): OMNI; detroit MI
• MDR Report Key: 4321059
• MDR Text Key: 5134954
• Report Number: 1418479-2014-00053
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/24/2014,11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• 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: 11/24/2014
• Distributor Facility Aware Date: 11/11/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1