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

Model Number	MAX-N
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional 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.As the device was not returned for evaluation, inspection was unable to be performed.The reported event could be attributed to: - mishandling of device.- simultaneous use with incompatible equipment.- excessive voltage applied by ancillary equipment.- sensor is left on patient for excessive time.The instructions for use (ifu) state: - inspect the sensor site periodically to ensure correct sensor alignment and adhesion.- do not attempt to repair, modify or clean sensor.- when uncertain about any measurement accuracy, check the patient¿s vital signs by alternate means; then make sure the pulse oximeter is working properly.- in conjunction to clinical signs and symptoms, pulse oximeter sensors are exclusively designed to be used as an adjunct in patient assessment.- sensor application errors, certain patient and ambient environmental conditions, can affect pulse oximeter¿s readings and signal.- any of the following conditions can cause inaccurate oxygen measurements - 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 light.Cover the sensor with opaque material if it is suspected that the transducer is exposed to excessive ambient light.- intravascular dyes.- excessive motion.Locate sensor at a stationary site and try to keep patient still.- plug the sensor into the pulse oximeter module and verify proper operations as described in the system operator¿s manual.If the sensor does not indicate reliable tracking of the pulse rate, relocate sensor to an alternative site or choose an alternative sensor.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that a pulse oximeter cord on an infant was found to have exposed wires.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 was provided and the reported lot number was shipped to multiple facilities.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed after the initial mdr was filed.A review of the dhr supports that the device is unlikely to have been released from stryker with the reported failure mode.
Event or Problem Description
It was reported that a pulse oximeter cord on an infant was found to have exposed wires.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 was provided and the reported lot number was shipped to multiple facilities.These are commonly used devices that are readily available.

• 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: 7039113
• Report Number: 0001056128-2017-00137
• Device Sequence Number: 19171978
• Product Code: NLF
• UDI-Device Identifier: 00885825014322
• UDI-Public: (01)00885825014322(17)200729(10)6827379
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K042316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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 Expiration Date: 07/29/2020
• Device Model Number: MAX-N
• Device Catalogue Number: MAX-NRR
• Device Lot Number: 6827379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1