MAUDE Adverse Event Report: MASIMO - 40 PARKER O3 REGIONAL OXIMETER MODULE

Model Number	24667
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported accuracy issues with the device.No patient impact or consequences were reported.Per the customer: 15 min into surgery: reposition head to left l 30% r 50% after few mins head was turned in straight position but the difference of 20-25% between left and right stays.After initialization of perfusion (heart lung machine) patient at 35 degrees celsius the difference between left and right to 40%.Left below 30% right around 60%.Left at one point even down to 5%.During perfusion l 20% right 60% difference is 40%.At end of perfusion difference increases left goes down to 10- 20%.Right stays the same during entire or (around 60%).After or patient no neurological damage.Surgical plan was adjusted according to what o3 showed (among other facts), during perfusion an aortic cross clamp was not used (while it usually would have been).
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection showed no damage.The module was connected to a root and successfully established communication.During testing the module was able to obtain measurements continuously and the measured values were consistent with a known good module and sensor.Internal inspection showed a contaminant on the female mating pin of the housing connector.The customer complaint was not duplicated however the contaminant on the housing connector was identified as a potential root cause of the reported issue.A service history record review reveals that this unit was in the field for over five (5) months with no previous reported issues related to this reported event.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported accuracy issues with the device.No patient impact or consequences were reported.Per the customer: 15 min into surgery: reposition head to left l 30% r 50% after few mins head was turned in straight position but the difference of 20-25% between left and right stays.After initialization of perfusion (heart lung machine) patient at 35 degrees celsius the difference between left and right to 40%.Left below 30% right around 60%.Left at one point even down to 5%.During perfusion l 20% right 60% difference is 40%.At end of perfusion difference increases left goes down to 10- 20%.Right stays the same during entire or (around 60%).After or patient no neurological damage.Surgical plan was adjusted according to what o3 showed (among other facts), during perfusion an aortic cross clamp was not used (while it usually would have been).

• Brand Name: O3 REGIONAL OXIMETER MODULE
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8453337
• Report Number: 2031172-2019-00146
• Device Sequence Number: 16192407
• Product Code: MUD
• UDI-Device Identifier: 00843997010771
• UDI-Public: 00843997010771
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K160526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 24667
• Device Catalogue Number: 9637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR