MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5 PULSE OXIMETER

Model Number	26818
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection showed no damage or defects.The device does not power on with lab stock batteries.The device was connected to an external power supply but does not power on and is observed to draw 170ma, exceeding 55ma at 6vdc for normal operational power draw.The circuit board was observed to warm up at component u7 on the instrument board, temperature measured at 113.2f (45.1c) after stabilizing for 30 minutes.This temperature did not exceed the maximum allowable limits (48c) of temperature safety requirements for surface contacted greater than 1 minute.No internal physical defect or damages observed via visual inspection without magnification.The customer complaint was duplicated, the short circuit prevents the device from powering on.A service history record review reveals that this unit was in the field for over two (2) months with no previous reported issues related to this reported event.(b)(6).
Event or Problem Description
The customer reported the rad-5 powered off suddenly.The device was hot and was unable to power on.No patient impact or consequences were reported.

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10088161
• Report Number: 3011353843-2020-00082
• Device Sequence Number: 3081598
• Product Code: DQA
• UDI-Device Identifier: 00843997005517
• UDI-Public: 00843997005517
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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: 26818
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1