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

Model Number	5100C-PA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the invos 5100c preamplifier provided low readings from the second channel.There is no allegation of patient injury.
Additional Manufacturer Narrative
One device was evaluated.Service center technician reported the plate covering and back covering is damaged.The unit was checked for function and electrical safety.All tests passed successfully.The reported condition was not confirmed.Product does not meet specification.The investigation found the device to function normally.No corrective action is required, because no failure mode was identified, since the product tested satisfactory.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 6841738
• Report Number: 8020893-2017-07679
• Device Sequence Number: 125346
• Product Code: MUD
• UDI-Device Identifier: 10884521145573
• UDI-Public: 10884521145573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080769
• 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): 01/11/2018

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-PA
• Device Catalogue Number: 5100C-PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1