MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5V PULSE OXIMETER

Model Number	25199
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(6).
Event or Problem Description
The customer reported that a segment was missing from the display.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned device was evaluated.Visual inspection upon receiving revealed no external damages or defects.Power-on test was performed.The device does turn on using batteries.The middle digit of the red led display on the device does not illuminate.The device was verified operationally and functionally.The device was able to obtain readings.The unit was found to visually and audibly alarm during alarm conditions.Internal inspection revealed a poor solder joint on q5 component causing the middle digit to not illuminate.When mechanical pressure was put on q5, the middle digit began illuminating.A service history record review reveals that this unit was in the field for over eight (8) months with no previous reported issues related to this reported event.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported that a segment was missing from the display.No consequences or impact to patient were reported.

• Brand Name: RAD-5V PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7916349
• Report Number: 2031172-2018-00480
• Device Sequence Number: 2255615
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: 25199
• Device Catalogue Number: 9197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1