MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-01-06 for SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES FGSP1018 manufactured by Spacelabs Medical Inc..
[177824905]
The complaint device was returned for evaluation. Visual evaluation found no anomalies. Device evaluation determined that the device fall time measurement failed confirming the reported malfunction. The main board was refurbished. The om board was replaced. A definitive root cause was not able to be determined; however, the most probable cause is that the device had been dropped previously during shipping. No further investigation is required. This type of event will continue to be monitored. It should be noted that this is being filed based on retrospective review.
Patient Sequence No: 1, Text Type: N, H10
[177824906]
Reportedly, post repair, c02 wave pattern and numbers disappear while on patient. There was no report of patient harm. No additional event or patient information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007409280-2020-00001 |
| MDR Report Key | 9555734 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2020-01-06 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNA VARGAS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 8004495328 |
| Manufacturer G1 | AVANTE HEALTH SOLUTIONS |
| Manufacturer Street | 212 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES |
| Generic Name | MULTIGAS ANALYZER MODULE |
| Product Code | CBR |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2018-12-12 |
| Model Number | FGSP1018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS MEDICAL INC. |
| Manufacturer Address | 5150 220TH AVE SE ISSAQUAH WA 98029 US 98029 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |