MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-8, VERTICAL; OXIMETER

Model Number	22043
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the device has been returned to the local facility, but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported the device is powering off by itself.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., corrected data:.

• Brand Name: RAD-8, VERTICAL
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7449706
• Report Number: 2031172-2018-00239
• Device Sequence Number: 1030725
• Product Code: DQA
• UDI-Device Identifier: 00843997005630
• UDI-Public: 00843997005630
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

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: Other
• Device Model Number: 22043
• Device Catalogue Number: 9191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 04/22/2018
• Supplement Report FDA Received Date: 05/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1