MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5 PULSE OXIMETER

Model Number 22330

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

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 the display is missing segments.No patient impact or consequences were reported.

Event Description

The customer reported the display is missing segments.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.External visual inspection found no damage.The unit powered on and off using battery power.One of the segments in the lower middle digit of the led display did not illuminate.A multimeter diode test found the non-illuminating diode of the display measured open instead of 1.8v for functioning segments.A defective 7-segment display component d5 on the system board causes the led segment to not illuminate.A service history record review reveals that this unit was in the field for over seven (7) years with no previous reported issues related to this reported event.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: tr1 3lj.

• Brand Name: RAD-5 PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11096549
• MDR Text Key: 224533209
• Report Number: 3011353843-2020-00213
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K033296
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22330
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1