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

Model Number 25052

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.Initial reporter zip code was unknown.For report submission, zip code entered as "00000".

Event Description

The customer reported the display freezes intermittently.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.The device powered on with battery power and ac power.The touch screen did not move without being touched, worked correctly, and did not flicker during the duration of the testing.The screen did not lock or freeze during the testing.The customer's complaint was not duplicated; however contamination damage was observed on the touch screen.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.Initial reporter zip code was unknown.For report submission, zip code entered as "00000".

Event Description

The customer reported the display freezes intermittently.No consequences or impact to patient 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: 10823440
• MDR Text Key: 216137354
• Report Number: 3011353843-2020-00181
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 25052
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1