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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND Back to Search Results
Catalog Number UNK_SUS
Device Problem No Device Output (1435)
Patient Problem Injury (2348)
Event Date 11/12/2018
Event Type  Injury  
Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The reported event originated from a medwatch report and the user facility is unknown.A supplemental mdr will be submitted with the final investigation results.The reported event will continue to be monitored through post-market surveillance.
 
Event Description
It was reported that a pulse oximeter probe was received from critical area and was unable to obtain or maintain patient oxygen saturation d/t.Pulse oximeter probe did not pick up reading.The event report type was reported to be a serious injury and it was reported that intervention was required.However, the event was not reported to be an adverse event.The reported event was submitted through a medwatch form and no follow up is possible as no facility or contact information, serial number or lot number were provided.These are commonly used devices that are readily available.
 
Manufacturer Narrative
The device was not returned to stryker sustainability solutions after the initial mdr was filed.As the device was not returned for evaluation, visual and functional inspections were unable to be performed.The reported event may be attributed to: failure to properly apply the sensor to the patient or to align the optical transducers.Application of sensor to an extremity with an arterial catheter, blood pressure cuff or intravascular infusion line in place.Application of sensor to a site that is too thick, thin or deeply pigmented.Venous pulsations if the sensor or supplemental tape is wrapped too tightly.Transducer exposure to excessive ambient light.Simultaneous use with intravascular dyes.Excessive patient motion.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 Description
It was reported that a pulse oximeter probe was received from critical area and was unable to obtain or maintain patient oxygen saturation d/t.Pulse oximeter probe did not pick up reading.The event report type was reported to be a serious injury and it was reported that intervention was required.However, the event was not reported to be an adverse event.The reported event was submitted through a medwatch form and no follow up is possible as no facility or contact information, serial number or lot number were provided.These are commonly used devices that are readily available.
 
Event Description
It was reported that a pulse oximeter probe was received from critical area and was unable to obtain or maintain patient oxygen saturation d/t.Pulse oximeter probe did not pick up reading.The event report type was reported to be a serious injury and it was reported that intervention was required.However, the event was not reported to be an adverse event.The reported event was submitted through a medwatch form and no follow up is possible as no facility or contact information, serial number or lot number were provided.These are commonly used devices that are readily available.
 
Manufacturer Narrative
On (b)(6) 2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.
 
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Brand Name
NA
Type of Device
NA
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5300 region ct
lakeland FL 33815
MDR Report Key8276295
MDR Text Key134060577
Report Number0001056128-2019-00010
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SUS
Was Device Available for Evaluation? No
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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