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

Model Number	25198
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
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 the display was defective due to a missing segment.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated which included functional testing.The device was returned without batteries but was turned on using generic stock batteries.Multiple led segments on the led digits did not illuminate.During the operational testing the unit provided both audible and visual alarms and passed simulation testing by providing accurate measurements.An internal inspection of the device was conducted and the unit was confirmed to have an open circuit in the failed led segment, resulting in led digits not lighting up.Led segment d2 failed, preventing all the digits on the screens to fully light up.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7401708
• Report Number: 2031172-2018-00198
• Device Sequence Number: 1221153
• Product Code: DQA
• UDI-Device Identifier: 00843997005913
• UDI-Public: 00843997005913
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K033296
• 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: 25198
• Device Catalogue Number: 9214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1