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

Model Number	24949
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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.
Event or Problem Description
The customer reported the radius-7 intermittently disconnects from the module.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported the radius-7 intermittently disconnects from the module.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.The unit powered on and off and passed functionality testing.A log file analysis was performed and one system fault was observed.The device will not be functional when this fault is present.The device was tested for 1 hour and there were no disconnects throughout the duration of the test.Contamination was observed under a component of the battery board during internal inspection.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: 12063152
• Report Number: 3011353843-2021-00145
• Device Sequence Number: 19938855
• Product Code: DQA
• UDI-Device Identifier: 00843997009249
• UDI-Public: 00843997009249
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/01/2021

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: 24949
• Device Catalogue Number: 9664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1