MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RADICAL-7 HANDHELD; OXIMETER

Model Number 22545

Device Problems Human-Device Interface Problem (2949); Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

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 touchscreen was not responding adequately and is turning off on its own.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.External visual inspection found no damage.The unit was able to power on and obtain measurements with all the enabled parameters.The touchscreen was not responsive on all segments of the display.The device was left powered on taking measurements for one hour and no failures were observed, device remained on throughout duration of the test.Internal inspection found contamination on the touchscreen flex cable pad which caused the touchscreen to be unresponsive.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 touchscreen was not responding adequately and is turning off on its own.No patient impact or consequences were reported.

• Brand Name: RADICAL-7 HANDHELD
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11382075
• MDR Text Key: 233737600
• Report Number: 3011353843-2021-00050
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: 00843997008358
• Combination Product (y/n): N
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22545
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1