MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; OXIMETER, REPROCESSED

Model Number	1859
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device was not returned to stryker sustainability solutions for evaluation.The device was not saved.As the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed.A review of the dhr could not be performed as the lot number was not reported.A review of internal procedures supports that the device was unlikely to have been released from stryker with the reported failure mode.The reported event may be attributed to: sensor not applied properly.Device is used in conditions where inaccurate readings are obtained.Patient motion.Ambient light.Failure of sensor or sensor circuit.Failure of led or led circuit.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the pulse oximeter sensor gave inaccurate readings.The facility reported that on a relatively sick patient, a procedure was aborted to resuscitate the patient from hypoxia with a tremendous a-a gradient, including the use of advanced testing like bedside echo, intracardiac echo and the facility was considering echmo.It was determined the patient wasn't really hypoxic.After getting abg results that conflicted with the data seen in the lab, the facility switched the probe, and the patient¿s saturation went from 68% to 100% immediately.The patient ended up going intubated to the icu after an aborted procedure.Multiple attempts were made to obtain clarity and additional information from the facility.No information was provided.

• Brand Name: NA
• Common Device Name: OXIMETER, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7287829
• Report Number: 0001056128-2018-00010
• Device Sequence Number: 1826741
• Product Code: NLF
• UDI-Device Identifier: 00885825015831
• UDI-Public: (01)00885825015831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1859
• Device Catalogue Number: 1859RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1