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
The product has been returned to masimo for evaluation.When the investigation is complete 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 reported issue, during opening of the sternum there was no value measurement of o3 for 1 minute.After that the r 37% and l 17% delta of 20% between l and r.Delta remains the same for 15 minutes than decreases to 10% for 10 mins.After that gradually increasing of delta again where l goes down to 0% and right to 30%.During procedure the values remain low r 40% and l 20-30%.Medical management was adjusted accordingly to o3 values, more inotropes were given.Temp during surgery 35-36 degrees celsius.
Event or Problem Description
The customer reported accuracy issues with the device.No patient impact or consequences were reported.Per the reported issue, during opening of the sternum there was no value measurement of o3 for 1 minute.After that the r 37% and l 17% delta of 20% between l and r.Delta remains the same for 15 minutes than decreases to 10% for 10 mins.After that gradually increasing of delta again where l goes down to 0% and right to 30%.During procedure the values remain low r 40% and l 20-30%.Medical management was adjusted accordingly to o3 values, more inotropes were given.Temp during surgery 35-36 degrees celsius.
Additional Manufacturer Narrative
Additional manufacuring 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 channel 2 only.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.

• 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: 8453407
• Report Number: 2031172-2019-00148
• Device Sequence Number: 2989028
• 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: 04/05/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR