MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND; OXIMETER, TISSUE SATURATION

Model Number	SAFB-SMX10
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the site of sensor application on patient had turned reddish black in color four days post-procedure.Medtronic has requested additional information associated with the complaint and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.
Additional Manufacturer Narrative
The sensor was visually examined for any anomalies.It was observed that there was material stuck to the sensor and the sensor was also damaged.The sensor should be returned with its patient side liner to prevent damage occurring.The sensor is designed for single use only and may not be re-used.The sensor was connected to a fi rsc-2 reusable sensor cable, fi pre-amplifier and the fi test-bed device.The sensor failed with a 'replace sensor' message coming up on the display screen and no rso2 values could be obtained.Because no information could be obtained from the sensor, and also the contamination/damage to the sensor, no further investigation could be carried out.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer reported that the site of sensor application on patient had turned reddish black in color 4 days later.There is patient involvement but patient harm is not clear at this time.

• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 6661763
• Report Number: 8020893-2017-06692
• Device Sequence Number: 1444643
• Product Code: MUD
• UDI-Device Identifier: 10884521104228
• UDI-Public: 10884521104228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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: Health Professional
• Device Model Number: SAFB-SMX10
• Device Catalogue Number: SAFB-SMX10
• Device Lot Number: A163601X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1