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

Model Number	25198
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional 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)(4).
Event or Problem Description
The customer reported the device has damage to the front case and shows low readings.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.The device was observed to have a damaged shell.Device was able to obtain measurements with all the enabled parameters.The device passed simulation tests and no product performance issue identified related to spo2 and pulse rate.A service history record review reveals that this unit was in the field for over four (4) 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: (b)(6).
Event or Problem Description
The customer reported the device has damage to the front case and shows low readings.No patient impact or consequences were reported.

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 52 discovery; irvine, CA 92618 ; 9498223661
• MDR Report Key: 12235319
• Report Number: 3011353843-2021-00174
• Device Sequence Number: 5403603
• Product Code: DQA
• UDI-Device Identifier: 00843997005517
• UDI-Public: 00843997005517
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 25198
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown