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

Model Number	25764
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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 the display had faded or missing segment.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found the battery cover missing.The unit powered on and off using battery power.Upon powering on, the unit issued a watchdog error and several display segments did not illuminate.Internal inspection found contaminant on several system board components, which resulted in loss of led segment illumination.A service history record review reveals that this unit was in the field for over four (4) 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: 421302.
Event or Problem Description
The customer reported the display had faded or missing segment.No patient impact or consequences were reported.

• Brand Name: PRONTO SPOT CHECK PULSE CO-OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11598746
• Report Number: 3011353843-2021-00074
• Device Sequence Number: 19737162
• Product Code: DQA
• UDI-Device Identifier: 00843997008921
• UDI-Public: 00843997008921
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 25764
• Device Catalogue Number: 9167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1