MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-03 for SPACELABS ULTRAVIEW SL MULTIGAS ANALYZER MODULE 91518 manufactured by Spacelabs Healthcare.
[1339808]
Spacelabs rec'd a report that a multigas analyzer module displayed question marks rather than agent values when a single agent was delivered. The display showed "des" and "sevo" and no agent values when delivering more than one agent. The report state that the device was working when case started and then exhibited the problem well into the case. The operation of the device did not affect pt outcome.
Patient Sequence No: 1, Text Type: D, B5
[8617174]
The device was returned to spacelabs (b)(4) for testing. Performance testing confirmed that the gas bench had malfunctioned. The gas bench was replaced and device operation confirmed. The customer's unit has been replaced. We have concluded that no further action is required and consider this issue closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2010-00014 |
| MDR Report Key | 1734897 |
| Report Source | 05 |
| Date Received | 2010-06-03 |
| Date of Report | 2010-06-03 |
| Date of Event | 2010-05-06 |
| Date Mfgr Received | 2010-05-06 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2011-04-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID GERAGHTY, MGR |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACELABS ULTRAVIEW SL MULTIGAS ANALYZER MODULE |
| Generic Name | ANESTHESIA GAS ANALYZER MODULE |
| Product Code | CBR |
| Date Received | 2010-06-03 |
| Returned To Mfg | 2010-05-13 |
| Model Number | 91518 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS HEALTHCARE |
| Manufacturer Address | 5150 220TH AVE SE ISSAQUAH WA 98027 US 98027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-03 |