FDA.report

MAUDE MDR 9851357

MDR report key
9851357
Report number
3011353843-2020-00043
Event key
0
Event type
3
Date of event
2020-02-10
Date received
2020-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Contact
STEFAN LISSMANN
Address
52 DISCOVERY IRVINE CA 92618 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RADICAL-7 HANDHELDOXIMETERMASIMO - 52 DISCOVERYDQA95009500R N

Patients

SequenceReceivedTreatmentOutcome
12020-03-180

Event Narratives

N

Patient 1

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.

D

Patient 1

THE CUSTOMER REPORTED AN ACCURACY ISSUE WITH SPHB. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

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06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550243APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550250APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550267APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550274APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550281APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550298APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550304APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550311APKAPK Technology Co.,Ltd.DQA2026-03-19

Related PMN/PMA Records By Product Code

TypeSubmissionProduct codeDeviceApplicantDecision date
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510(k)K253887DQANasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme2026-05-01
510(k)K260931DQAUnimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.2026-04-14
510(k)K252448DQAAViTA Pulse Oximeter (SP61)Avita Corporation2026-02-27
510(k)K252805DQAYUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-17