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

Model Number	5100C-PA
Medical Device Problem Codes	False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2018
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
According to the reporter, during the procedure, the device had a reading issue: the value of around 40 which appeared on the monitor did not match with the curve around 80.The customer reported no patient harm.
Additional Manufacturer Narrative
Evaluation summary: one device was evaluated.Service center technician reported that there was no failure was found.The investigation found the device to function normally.The reported product was not related to a reported complaint event.There was no fault with the pre amp unit.The failure was attributed to the monitor which was also returned for investigation.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the device had reading issue, the value of around 40 which appeared on the monitor did not match with the curve around 80.This was also tested a few days later, same thing happened.The range difference was not as big as in the patient's case.The customer reported no patient injury.
Additional Manufacturer Narrative
Correction: d3 additional information: d8, g1, g3, h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway 20023 3; EI 200233
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway 20023 3; EI 200233
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, MA 55112 ; 7635265677
• MDR Report Key: 7568628
• Report Number: 8020893-2018-00248
• Device Sequence Number: 11311226
• Product Code: MUD
• UDI-Device Identifier: 10884521145573
• UDI-Public: 10884521145573
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

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: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 08/08/2024
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 12/26/2018; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 64 KG