MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-8, HORIZONTAL; OXIMETER

Model Number	26816
Medical Device Problem Code	Device Alarm System (1012)
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
Additional manufacturing narrative: other, the product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted., other text: initial reporter phone # is entered as (b)(4) to meet the minimum allowable characters.Initial reporter phone # is: (b)(4).
Event or Problem Description
The customer reported the rad-8 does not alarm when on nurse call.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.No external defects were observed during visual inspection.The unit powered on and off using both battery power and ac power.Additional tests were performed and the nurse call polarity, as received, was set to "inverse" and correctly changed from short circuit to open circuit once the alarm limits were triggered.Both inverse and normal polarity were tested and found functioning as designed.Internal inspection found a damaged capacitor (c200) on the system board; however the reported issue was not duplicated.A service history record review reveals that this unit was in the field for over five (5) months with no previous reported issues related to this reported event.Initial reporter phone # is entered as "(b)(6)" to meet the minimum allowable characters.Initial reporter phone # is: (b)(6).
Event or Problem Description
The customer reported the rad-8 does not alarm when on nurse call.No consequences or impact to patient were reported.

• Brand Name: RAD-8, HORIZONTAL
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11527301
• Report Number: 3011353843-2021-00068
• Device Sequence Number: 17457321
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: 00843997005647
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 26816
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1