MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RED DBI-DC8; OXIMETER

Model Number 2644

Device Problem Sensing Intermittently (1558)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring 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.

Event Description

The customer reported that the sensors suddenly stopped working.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned sensor was evaluated and passed visual inspection since no physical damage was observed.The unit failed continuity tests due to a short in the cable between the detector circuit and inner shield, along the length of the cable.The sensor is malfunctioning and a ¿sensor off patient" error message displayed on the lab monitor., corrected data: updated d4 lot# from "2h275" to a blank field.

Event Description

The customer reported that the sensors suddenly stopped working.No consequences or impact to patient were reported.

• Brand Name: RED DBI-DC8
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11417942
• MDR Text Key: 238666473
• Report Number: 3011353843-2021-00055
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K090662
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2644
• Device Catalogue Number: 2644
• Device Lot Number: 2H275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1