MAUDE Adverse Event Report: MASIMO - 40 PARKER KIT, RADIUS-7; OXIMETER

Model Number	24950
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2019
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.
Event or Problem Description
The customer reported intermittent operation of the radius-7 module when the sensor is plugged in.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The instrument module was able to pair with a known good battery module and together they were able to connect to a known good root.Tapping and hitting the module did not cause any disconnects.The module was able to get measurements with a known good sensor continuously for 15 minutes.No internal defects or damages were observed.The customer's complaint was not duplicated.The instrument module is fully functional.
Event or Problem Description
The customer reported intermittent operation of the radius-7 module when the sensor is plugged in.No patient impact or consequences were reported.

• Brand Name: KIT, RADIUS-7
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8634668
• Report Number: 2031172-2019-00257
• Device Sequence Number: 13954554
• Product Code: DQA
• UDI-Device Identifier: 00843997009249
• UDI-Public: 00843997009249
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153225
• 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): 05/01/2019

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: 24950
• Device Catalogue Number: 9664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1