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

Model Number 22042

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

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 Description

The customer reported the unit won't stay on.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection found no external damage or defects.The unit powered on and off using ac power and dc power, but the unit restarts continuously as soon as it is powered on and doesn't remain on.Internal inspection found contamination damages on the cable connector from the system board to ui board.There was also contamination damages on the ui board, led display circuit board, and the cable connecting the ui board to the keypad.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.

Event Description

The customer reported the unit won't stay on.No patient impact or consequences were reported.

• Brand Name: RAD-8, HORIZONTAL
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11350898
• MDR Text Key: 233060391
• Report Number: 3011353843-2021-00042
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: 00843997005647
• Combination Product (y/n): N
• PMA/PMN Number: K053269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22042
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1