MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-08 for SPACELABS MULTIGAS ANALYZER MODULE 91518 manufactured by Spacelabs Medical Inc..
[2654312]
Spacelabs received information that alleges that a multigas analyzer module failed.
Patient Sequence No: 1, Text Type: D, B5
[3052655]
Spacelabs received information that alleges that a multigas analyzer module failed.
Patient Sequence No: 1, Text Type: D, B5
[9968326]
Spacelabs is working to contact the hospital to obtain details of the reported equipment malfunction. No one has been injured as a result of this alleged malfunction. We will provide a supplemental report once our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[10198434]
The customer reported three device failures and stated that they were safety issues. We filed an mdr because of the customer's concern. We documented the other two in mdrs 3023361-2012-00020 and 3023361-2012-00021. The subject device was first sent by the customer to their service provider who was unable to fix the issue. The device was then returned to spacelabs for repair. Spacelabs replaced the gas bench and solved the issue. The device was returned to the hospital and put back into service. There has been no further report on this issue. The gas bench is an oem product. Spacelabs replaced the gas bench in question and returned it to the manufacturer for investigation and trending. Ge has not indicated there is a significant trend of this failure. No one has been injured as a result of this failure. We have concluded that this report is final and consider this issue closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2012-00019 |
| MDR Report Key | 2564426 |
| Report Source | 05 |
| Date Received | 2012-05-08 |
| Date of Report | 2012-09-06 |
| Date of Event | 2012-04-15 |
| Date Mfgr Received | 2012-04-16 |
| Device Manufacturer Date | 2006-07-18 |
| Date Added to Maude | 2012-09-19 |
| 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 | MS MIAOMIAO ZHENG |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Manufacturer G1 | SPACELABS MEDICAL INC. |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98029 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACELABS MULTIGAS ANALYZER MODULE |
| Generic Name | ANESTHESIA GAS ANALYZER MODULE |
| Product Code | CBR |
| Date Received | 2012-05-08 |
| Returned To Mfg | 2012-01-25 |
| Model Number | 91518 |
| ID Number | V1.00.11 |
| Device Expiration Date | 2012-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2012-05-08 |