MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-28 for SEDLINE 2479 manufactured by Masimo - 40 Parker.
[81378604]
(if other): it was indicated by the customer that the sensor used during the reported event has been discarded; and therefore, could not be returned to masimo for evaluation. If new information is obtained or the product is returned, a follow up report will be submitted. (b)(6):
Patient Sequence No: 1, Text Type: N, H10
[81378605]
The customer reported while performing a mastectomy psi was 20-21 during intubation, so dr. (b)(6) thought the depth of anesthesia was fine. However, suddenly hr went up. Therefore, he increased dose of remifentanil. After surgery he asked the patient about intubation. She was not suffered from intubation but remembered about intubation. (she did not open her eyes because of muscle relaxant. ) he asked possible reason why psi was below 25 even, she remembered this event. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00737 |
| MDR Report Key | 6752856 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-28 |
| Date of Event | 2017-07-01 |
| Date Mfgr Received | 2017-07-02 |
| Date Added to Maude | 2017-07-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEFAN LISSMANN |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 926181604 |
| Manufacturer Country | US |
| Manufacturer Postal | 926181604 |
| Manufacturer Phone | 9492977000 |
| Manufacturer G1 | INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V. |
| Manufacturer Street | CALZADA DEL ORO, NO. 2001 PARQUE INDUSTRIAL PALACO |
| Manufacturer City | MEXICALI, BAJA CALIFORNIA 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDLINE |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-07-28 |
| Model Number | 2479 |
| Catalog Number | 2479 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 40 PARKER |
| Manufacturer Address | 40 PARKER IRVINE CA 926181604 US 926181604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-28 |