MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RC25-4RA EMS, RAINBOW PATIENT CABLE; OXIMETER

Model Number 4485

Device Problems Incorrect Measurement (1383); Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

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 that the cable provided "confused values" or an error message.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.No physical damage was observed during visual inspection.During continuity testing with a tester, there was an open in the cable on the green conductor, inside the bend relief area of the m15 connector.Testing with a monitor showed a "sensor off" error message displayed and an audible and visual alarm.The cable is malfunctioning and is unable to perform spo2 and pulse rate simulation tests.

Event Description

The customer reported that the cable provided "confused values" or an error message.No consequences or impact to patient were reported.

• Brand Name: RC25-4RA EMS, RAINBOW PATIENT CABLE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 12100781
• MDR Text Key: 260266878
• Report Number: 3011353843-2021-00154
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997013420
• UDI-Public: 00843997013420
• Combination Product (y/n): N
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4485
• Device Catalogue Number: 4485
• Device Lot Number: 20CEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1