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

Model Number	24970
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/28/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation, the device passed all visual and functional testing.The radius-7 unit was found to visually and audibly alarm during alarm conditions and was determined to be functioning as designed.Additionally, no issues were detected with the concomitant root or patient safetynet system.A review of log files from the event confirmed the presence of clinical alarms as well as non-clinical events.This review also confirmed the involved devices were able to successfully communicate notifications with each other and via the paging transmitter.The reported issue was not confirmed.
Event or Problem Description
It was reported: "nursing staff and a physician were present at the patient bedside when the patient was found without a pulse.The telemetry tech from pcu called to say the patient was in asystole at that time.A rapid response was already underway.Staff stated the monitor did not alarm in the room nor was the staff pager initiated." per the customer, the patient was transferred to the icu as the safetynet system and bedside monitors failed to notifiy clinicians regarding the patient condition.The patient passed away in the icu.

• Brand Name: RADIUS-7
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7208569
• Report Number: 2031172-2018-00024
• Device Sequence Number: 1174692
• 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: K153225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24970
• Device Catalogue Number: 9664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR
• Patient Weight: 77