MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-57 CONFIGURABLE PULSE CO-OXIMETER

Model Number 25195

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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 leds are missing in both the top and lower display.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.When powered on it was observed that three led segments are missing.The unit was able to obtain readings and alarmed audibly and visually under alarm conditions.Internal inspection observed open circuits on 2 defective led segments on component d2 and 1 led segment on d1 on the instrument board.The open circuits result in 3 led segments not illuminating.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 exceeded the maximum allowable characters, zip code is as follows: (b)(6).

Event Description

The customer reported leds are missing in both the top and lower display.No patient impact or consequences were reported.

• Brand Name: RAD-57 CONFIGURABLE PULSE CO-OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9435597
• MDR Text Key: 174879296
• Report Number: 3011353843-2019-00133
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997006163
• UDI-Public: 00843997006163
• Combination Product (y/n): N
• PMA/PMN Number: K080238
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25195
• Device Catalogue Number: 9216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1