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

Model Number	5100C-EU
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the unit's saturation rate was high on the right side.There was no allegation of patient death or serious injury.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNET IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 7068462
• Report Number: 2936999-2017-05612
• Device Sequence Number: 19268692
• Product Code: MUD
• UDI-Device Identifier: 10884521211179
• UDI-Public: 10884521211179
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K080769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 5100C-EU
• Device Catalogue Number: 5100C-EU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1