MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-25 for UVSL MULTIGAS ANALYZER D-91518-A manufactured by Spacelabs Healthcare.
[20241303]
The hospital used a spacelabs gas analyzer demonstration unit during a procedure, under the observation of a spacelabs sales representative. The analyzer failed during the procedure, with the result that gas was not monitored for approximately 10 minutes while the unit was replaced. There was no claim of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[20543968]
The gas analyzer involved is now being returned to spacelabs for evaluation. The case remains under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2008-00050 |
| MDR Report Key | 1136151 |
| Report Source | 05 |
| Date Received | 2008-08-25 |
| Date of Report | 2008-08-22 |
| Date of Event | 2008-02-25 |
| Date Mfgr Received | 2008-02-26 |
| Device Manufacturer Date | 2007-09-04 |
| Date Added to Maude | 2008-11-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GARY PARKER, MGR. |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UVSL MULTIGAS ANALYZER |
| Generic Name | NONE |
| Product Code | CBR |
| Date Received | 2008-08-25 |
| Model Number | D-91518-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1266545 |
| Manufacturer | SPACELABS HEALTHCARE |
| Manufacturer Address | PO BOX 7018 ISSAQUAH WA 98027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-25 |