MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY KIT, RAD-97 PULSE CO-OXIMETER

Model Number 26242

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

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.

Event Description

The customer reported the speaker is not alarming.No patient impact or consequences were reported.

Event Description

The customer reported the speaker is not alarming.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other text: the returned device was evaluated.The device powered on and off using both battery and ac power.All alarm conditions were audible and visual; however the speaker sounded low even when at full volume.Internal inspection found that the speaker was loose inside the device due to a broken technology board pole and a cracked connectivity board.The customer's complaint was not duplicated during testing.A service history record review reveals that this unit was in the field for over eleven (11) months with no previous reported issues related to this reported event.

• Brand Name: KIT, RAD-97 PULSE CO-OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10945317
• MDR Text Key: 219496181
• Report Number: 3011353843-2020-00194
• Device Sequence Number: 1
• Product Code: MWI
• UDI-Device Identifier: 00843997012317
• UDI-Public: 00843997012317
• Combination Product (y/n): N
• PMA/PMN Number: K170168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26242
• Device Catalogue Number: 9738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1