FDA.report

MAUDE MDR 9714867

MDR report key
9714867
Report number
3011353843-2020-00018
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-02-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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 DISCOVERYDQA250529500Y R

Patients

SequenceReceivedTreatmentOutcome
12020-02-140

Event Narratives

N

Patient 1

ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

D

Patient 1

THE CUSTOMER REPORTED THE DEVICE SOMETIMES SWITCHES OFF WITH NO REASON EVEN IF THE BATTERY IS FULLY CHARGED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

Related GUDID Devices By Product Code

Primary DIBrandCompanyProduct codePublished
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
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
510(k)K252655DQAPulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.2026-05-11
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