N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9814038
- MDR report key
- 9814038
- Report number
- 2936999-2020-00200
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-14
- Date received
- 2020-03-10
- 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
- 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 | DOC10 | DOC10 | N | R |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-10 | 0 |
Event Narratives
D
Patient 1
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD FALSE/UNRELIABLE READING OF THE SPO2 AND THE PLETH. THEY REPLACED THE SENSOR WITH A NEW CABLE, BUT THE ISSUE WAS REMAINING INADEQUATE READING. IT WAS NEVER CLEAR WHEN EXACTLY THE FALSE VALUE DID APPEAR. IT WAS ON SEVERAL DIFFERENT CHILDREN WITH DIFFERENT CONDITIONS. THERE WAS NO PATIENT 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 |