MAUDE Adverse Event Report: MASIMO - 40 PARKER PRONTO SPOT CHECK PULSE CO-OXIMETER

Model Number	25212
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
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 that the sphb readings are incorrect.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alert conditions.During simulation testing, the device was found to provide accurate measurements.No performance issues were identified.The reported issue was unable to be confirmed.
Event or Problem Description
The customer reported that the sphb readings are incorrect.No patient impact or consequences were reported.

• Brand Name: PRONTO SPOT CHECK PULSE CO-OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7871427
• Report Number: 2031172-2018-00470
• Device Sequence Number: 11291217
• Product Code: DQA
• UDI-Device Identifier: 00843997008921
• UDI-Public: 00843997008921
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K091057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 25212
• Device Catalogue Number: 9167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1