MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-04 for FLOW SELECTOR VALVE SC 603-A * manufactured by Instrumentation Industries, Inc..
[465214]
Patient admitted and underwent open heart surgery. Post-up, patient was on o2 nasal cannula. Patient was transferred from sicu to n2w. Patient assisted to bed. O2 nasal cannula connected to gauge with toggle switch. The toggle switch was noted to be in the incorrect position and the o2 was noted to be in the incorrect position and the o2 was not flowing to the patient. The patient's o2 was not flowing to the patient. The patient's o2 stats dropped to 50's. Patient placed on 100% non-rebreather mask and transferred back to sicu for further treatment. Switch is not marked and is very confusing to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 698700 |
| MDR Report Key | 698700 |
| Date Received | 2005-10-04 |
| Date of Report | 2005-08-19 |
| Date of Event | 2005-08-19 |
| Date Facility Aware | 2005-08-19 |
| Report Date | 2005-08-19 |
| Date Reported to Mfgr | 2005-08-31 |
| Date Added to Maude | 2006-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOW SELECTOR VALVE |
| Generic Name | RESPIRATORY OXYGEN GAUGE VALVE |
| Product Code | BXY |
| Date Received | 2005-10-04 |
| Model Number | SC 603-A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 687788 |
| Manufacturer | INSTRUMENTATION INDUSTRIES, INC. |
| Manufacturer Address | * BETHEL PARK PA * US |
| Baseline Brand Name | FLOW SELECTOR VALVE |
| Baseline Generic Name | O2 FLOW SELECTOR VALVE |
| Baseline Model No | SC 603-A |
| Baseline Catalog No | SC 603-A |
| Baseline ID | NA |
| Baseline Device Family | PRESSURE TUBING AND ACCESSORIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-10-04 |