MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-67 SPOT CHECK PULSE CO-OXIMETER

Model Number	25870
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2019
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.Device not returned.
Event or Problem Description
The customer reported the device is providing high sphb readings when compared to a blood draw.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the device is providing high sphb readings when compared to a blood draw.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The device was able to power on using both ac and battery power and was able to obtain readings and alarmed audibly and visually when alarm limits were breached.Device accuracy testing was performed with passing results.Trend data was reviewed and showed a gender was specified for approximately 86% of customer's sphb measurements.Per the rad-67 operator¿s manual: ¿when using a compatible sensor, ensure the gender has been entered correctly.Entering an incorrect gender may affect measurement performance of the device¿.Further communication with the customer has indicated that the device performed within accuracy specifications.The customer complaint was not duplicated as the device is functioning as designed.

• Brand Name: RAD-67 SPOT CHECK PULSE CO-OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618 1604
• MDR Report Key: 9132121
• Report Number: 3011353843-2019-00072
• Device Sequence Number: 11395234
• Product Code: DQA
• UDI-Device Identifier: 00843997012812
• UDI-Public: 00843997012812
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 25870
• Device Catalogue Number: 9794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1