FDA.report

MAUDE MDR 9735410

MDR report key
9735410
Report number
3011353843-2020-00022
Event key
0
Event type
3
Date of event
2020-01-24
Date received
2020-02-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1RAD-8, HORIZONTALOXIMETERMASIMO - 52 DISCOVERYDQA220429190N R

Patients

SequenceReceivedTreatmentOutcome
12020-02-200

Event Narratives

N

Patient 1

ADDITIONAL MANUFACTURING NARRATIVE: OTHER, THE PRODUCT HAS BEEN RETURNED TO THE LOCAL FACILITY BUT HAS NOT YET BEEN RECEIVED AT THE MAIN OFFICE FOR EVALUATION. ONCE RETURNED AND INVESTIGATED, A FOLLOW-UP REPORT WILL BE SUBMITTED., OTHER TEXT: INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6).

D

Patient 1

THE CUSTOMER REPORTED THE DEVICE DOES NOT POWER ON AND THE MAINS INLET/EMI FILTER WAS OBSERVED SPARKING AND CRACKLING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

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06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
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06946725550304APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550311APKAPK Technology Co.,Ltd.DQA2026-03-19

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