MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5 PULSE OXIMETER

Model Number	25198
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
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.(b)(6).
Event or Problem Description
The customer reported inaccurate readings.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported inaccurate readings.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.The device powered on using battery power however two segments on the led display did not turn on.The device passed functional testing and was found to visually and audibly alarm during alarm conditions.During simulation testing, the device passed manual and preset conditions.No product performance issue was identified related to spo2 and pulse rate.Contamination was found on the instrument board which caused the segments on the led display to not power on.A service history record review reveals that this unit was in the field for over three (3) years 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).

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10408004
• Report Number: 3011353843-2020-00132
• Device Sequence Number: 3092448
• Product Code: DQA
• UDI-Device Identifier: 00843997005517
• UDI-Public: 00843997005517
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033296
• 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): 07/23/2020

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: 25198
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1