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..
[2655320]
Spacelabs received information that alleges that a multigas analyzer module failed.
Patient Sequence No: 1, Text Type: D, B5
[9965436]
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
[18805991]
The customer reported three device failures and stated that they were safety issues. We filed three mdrs because of the customer's concern. We documented the other two in mdrs 3023361-2012-00019 and 3023361-2012-00021. The subject device was sent to the customer's service provider and repaired by replacing a cpu board. The device was returned to service. There has been no further report on this issue. A review of available data in the complaint database does not indicate that this malfunction is part of a trend. 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
[18978127]
Spacelabs received information that alleges that a multigas analyzer module failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3023361-2012-00020 |
| MDR Report Key | 2564461 |
| 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 | 2006-07-05 |
| 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 |
| Model Number | 91518 |
| ID Number | V1.00.11 |
| Device Expiration Date | 2008-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |