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 2017-07-21 for SEDLINE KIT 25761 9513 manufactured by Masimo - 40 Parker.
[80634953]
Multiple attempts for product return and requests for additional information were made. The product has not been returned to masimo to allow an analysis to be performed. 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
[80634954]
The customer reported the following issue: "there happened the issue that ct impedance indicator became blue. However the replacement module resolved the issue. There was no problem with the sensor. The impedance reading was 10 times compared to the typical. Also, there was another issue. Although a patient was under sedation, the issue that psi value was very high occurred several times. " no patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031172-2017-00731 |
| MDR Report Key | 6731067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-21 |
| Date of Event | 2017-06-27 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 2017-04-24 |
| Date Added to Maude | 2017-07-21 |
| 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 KIT |
| Generic Name | ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2017-07-21 |
| Returned To Mfg | 2017-07-25 |
| Model Number | 25761 |
| Catalog Number | 9513 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-07-21 |