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

Model Number 22045

Device Problems Incorrect Measurement (1383); Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

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.(b)(6).

Event Description

The customer reported inaccurate values and signal loss.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

Event Description

The customer reported inaccurate values and signal loss.No consequences or impact to patient were reported.

• Brand Name: RAD-8, VERTICAL
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10658124
• MDR Text Key: 210715053
• Report Number: 3011353843-2020-00158
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997005630
• UDI-Public: 00843997005630
• Combination Product (y/n): N
• PMA/PMN Number: K053269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22045
• Device Catalogue Number: 9191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1