MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-27 for CAPNOGRAPH 90513 manufactured by Spacelabs Medical, Inc..
[10532]
Anesthesiologist doing random check of wasted anesthesia gas in the or, discovered an opening in the rear of the machine. Wasted anesthesia gases were detected and measured from the opening. Mfr notified and is providing tubing to connect the machine to the anesthesia machine's waste gas scavenging system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002601 |
| MDR Report Key | 14346 |
| Date Received | 1994-06-27 |
| Date of Report | 1994-06-01 |
| Date of Event | 1994-05-16 |
| Date Added to Maude | 1994-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPNOGRAPH |
| Generic Name | ANESTHESIA GAS MONITOR |
| Product Code | CBR |
| Date Received | 1994-06-27 |
| Model Number | 90513 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 14342 |
| Manufacturer | SPACELABS MEDICAL, INC. |
| Manufacturer Address | REDMOND WA 980739713 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-06-27 |