MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-08 for SPACELABS MULTIGAS MODULE 92518 manufactured by Spacelabs Medical Inc..
[4808042]
The customer has a 92518 gas module connected to xprezzon monitor. The customer reported, "the gas parameter began to flicker and blink, then finally lost communication. "
Patient Sequence No: 1, Text Type: D, B5
[12332876]
No one was injured as a result of this event. Spacelabs is evaluating this event and will file a f/u report when our eval is concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2013-00029 |
| MDR Report Key | 3211572 |
| Report Source | 07 |
| Date Received | 2013-07-08 |
| Date of Report | 2013-04-24 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-04-03 |
| Device Manufacturer Date | 2012-09-24 |
| Date Added to Maude | 2014-09-10 |
| 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 Street | 35301 SE CTR ST |
| Manufacturer City | SNOQUALMIE WA 98065 |
| Manufacturer Country | US |
| Manufacturer Postal | 98065 |
| Manufacturer Phone | 4253635915 |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98029 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACELABS MULTIGAS MODULE |
| Generic Name | CBR: MULTIGAS ANALYZER |
| Product Code | CBR |
| Date Received | 2013-07-08 |
| Model Number | 92518 |
| ID Number | 1.00.01 |
| Device Expiration Date | 2014-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS MEDICAL INC. |
| Manufacturer Address | ISSAQUAH WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-08 |