MAUDE Adverse Event Report: COVIDIEN 90043086 30007 HEAD REST 7" BAGE X72; FOAM POSITIONING HEAD RES

Model Number	31143145
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 02/20/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a foam positioning head rest.The customer reports 7" head rest inner cutout is much bigger than usual.

• Brand Name: 90043086 30007 HEAD REST 7" BAGE X72
• Common Device Name: FOAM POSITIONING HEAD RES
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield
• MDR Report Key: 6342989
• Report Number: 1282497-2017-00235
• Device Sequence Number: 1503300
• Product Code: CCX
• UDI-Device Identifier: 20884527003379
• UDI-Public: 0120884527003379100017857710
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2017

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
• Operator of Device: Other
• Device Model Number: 31143145
• Device Catalogue Number: 31143145
• Device Lot Number: 17857710
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/20/2017
• Patient Sequence Number: 1