N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9811865
- MDR report key
- 9811865
- Report number
- 2936999-2020-00198
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-17
- Date received
- 2020-03-10
- 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
- AVI KLUGER
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 303-303-3035
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NELLCOR | OXIMETER | MEDIANA CO. LTD. | DQA | 10005941 | 10005941 | * | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-10 | 0 |
Event Narratives
D
Patient 1
ACCORDING TO THE REPORTER, THE UNIT HAD LOW SPO2 READING. IT WAS INDICATED THAT DESATURATION AND TACHYCARDIA RECORD FOR SPO2 READINGS WAS 76% AND HEART RATE OF 239 BUT NEWBORN DID NOT MANIFEST ANY SIGNS OF DISTRESS. FOLLOW UP REPORT STATED THAT THERE WAS NO DEATH OR ANY PATIENT INJURY ACCOMPANIED WITH CUSTOMER COMPLAINT ON THE FLUCTUATION OF READING AND THE FIRST FEEDBACK WAS NOT ACCURATE AND WAS RELATED TO ANOTHER EVENT.
Related GUDID Devices By Product Code
Related PMN/PMA Records By Product Code
| Type | Submission | Product code | Device | Applicant | Decision date |
|---|---|---|---|---|---|
| 510(k) | K252655 | DQA | Pulse 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) | K253887 | DQA | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | 2026-05-01 |
| 510(k) | K260931 | DQA | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | 2026-04-14 |
| 510(k) | K252448 | DQA | AViTA Pulse Oximeter (SP61) | Avita Corporation | 2026-02-27 |
| 510(k) | K252805 | DQA | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 |