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	03/06/2019
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: 2 hrs in surgery: perfusion start and cooling down, gradually declining values.After 1 hr selective cerebral perfusion both sides of brain temp 36.9.22 mins later selective brain perfusion stopped.Then the delta between l and r increases to 15-20% left 18% right 33%.Eeg very low activity/almost absent (burst suppression (psi 0-1), medical management adjusted accordingly.It was expected that rso2 would increase with low brain activity due lower o2 consumption.Because that didn¿t happen, the brain perfusion was increased from 650 ml/min 750ml/min.Values remained the same.Blood gas showed normal pao2 levels, high saturation 98%.Next step was rbc was given and co2 was increased on heart lung machine to optimize oxygenation of the brain.None of these interventions had effect on the values of o3.Temp during this was around 26 degrees.O3 l sensor replaced by new one, caused short increase of 7% but dropped to 18% soon after.Invos connected instead of o3, showed values of around 50% with small delta between left and right.Left was changed back to o3, with increasing of the temp.The values increased to 50%, at the end of the procedure were down to 41% again (baseline).
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.The module was placed in the test fixture and measurements were obtainable on one of the two channels.The obtained measurements were continuous with cable and connector manipulation and the recorded values were consistent with a known good module.Internal inspection showed contaminant on the female mating pin of the module.The customer complaint was not duplicated; however, the presence of the contaminant is a possible root cause of the reported complaint.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.
Event or Problem Description
The customer reported accuracy issues with the device.No patient impact or consequences were reported.Per the customer: 2hrs in surgery: perfusion start and cooling down, gradually declining values.After 1 hr selective cerebral perfusion both sides of brain temp 36.9.22 mins later selective brain perfusion stopped.Then the delta between l and r increases to 15-20% left 18% right 33%.Eeg very low activity/almost absent (burst suppression (psi 0-1), medical management adjusted accordingly.It was expected that rso2 would increase with low brain activity due lower o2 consumption.Because that didn¿t happen, the brain perfusion was increased from 650 ml/min 750ml/min.Values remained the same.Blood gas showed normal pao2 levels, high saturation 98%.Next step was rbc was given and co2 was increased on heart lung machine to optimize oxygenation of the brain.None of these interventions had effect on the values of o3.Temp during this was around 26 degrees.O3 l sensor replaced by new one, caused short increase of 7% but dropped to 18% soon after.Invos connected instead of o3, showed values of around 50% with small delta between left and right.Left was changed back to o3, with increasing of the temp.The values increased to 50%, at the end of the procedure were down to 41% again (baseline).

• 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: 8453374
• Report Number: 2031172-2019-00147
• Device Sequence Number: 10823021
• 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: 03/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: O3 ADULT SENSOR
• Patient Age: 76 YR