MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY KIT, RADIUS-7; OXIMETER

Model Number	26945
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2020
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.
Event or Problem Description
The customer reported the device will not hold a signal.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the device will not hold a signal.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed signed of contamination on the contact points of the top shell.When powered on the device was unable to obtain readings and displayed a replace cable error message.Internal inspection showed contamination damage on the pogo pins of the rd15 sensor flex cable causing the replace cable error message.The sensor flex cable was replaced and the device was able to obtain readings.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.

• Brand Name: KIT, RADIUS-7
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11140548
• Report Number: 3011353843-2021-00005
• Device Sequence Number: 897568
• Product Code: DQA
• UDI-Device Identifier: 00843997009249
• UDI-Public: 00843997009249
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 26945
• Device Catalogue Number: 9664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1