N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9835969
- MDR report key
- 9835969
- Report number
- 2936999-2020-00208
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-09
- Date received
- 2020-03-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- 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 | NELLCOR PURITAN BENNETT MEXICO SA | DQA | DS100A-1 | DS100A-1 | * | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-16 | 0 |
Event Narratives
D
Patient 1
ACCORDING TO THE REPORTER, THE DEVICE PARAMETER WAS BROKEN, STATING THAT THE MONITOR WAS NOT PUMPING. IT WAS ALSO INDICATED THAT THE SENSOR WAS SHOWING SPO2 READING OF 94% WITH 100% OXYGEN. THE SENSOR WAS REPLACED. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.
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 |