MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-09 for SPACELABS MULTIGAS ANALYZER MODULE 91518 manufactured by Spacelabs Medical Inc..
[2837729]
Spacelabs received a report that a multigas analyzer module displayed "isoflurane" when the agent desflurane was delivered. The display showed question marks rather than agent values.
Patient Sequence No: 1, Text Type: D, B5
[9984023]
The subject device was returned to spacelabs for investigation. Testing carried out by the equipment service center (esc) identified the root cause as a defective optical bench in the multigas analyzer assembly. The display "isoflurane" when the desflurane agent was delivered was due to the failure of the optical bench. The question marks (??? ) displayed in the gas analysis parameter field indicated the identification of out-of-range data. This is by design as a mitigation to alert the user to an issue with the analyzer that requires the user's intervention. The operations manual for the multigas analyzer explains the conditions with question marks. The customer's unit has been replaced. No one has been injured as a result of this malfunction. This supplemental report is considered final and the issue is closed.
Patient Sequence No: 1, Text Type: N, H10
[19422127]
Spacelabs received a report that a multigas analyzer module displayed "insoflurance" when the agent desaflurance was delivered. The display showed question marks rather than agent values.
Patient Sequence No: 1, Text Type: D, B5
[19474298]
The customer's unit has been replaced. Spacelabs received the returned subject device on april 04, 2012 for investigation. No one has been injured as a result of this malfunction. We will provide a supplemental report once additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2012-00013 |
| MDR Report Key | 2523509 |
| Report Source | 05 |
| Date Received | 2012-04-09 |
| Date of Report | 2012-07-25 |
| Date of Event | 2012-03-21 |
| Date Mfgr Received | 2012-03-21 |
| Device Manufacturer Date | 2009-09-22 |
| Date Added to Maude | 2012-09-10 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | RL |
| 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 | 2012-04-09 |
| Returned To Mfg | 2012-04-04 |
| Model Number | 91518 |
| Device Expiration Date | 2011-11-22 |
| 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 | 2012-04-09 |