MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-02 for SPACELABS MULTIGAS MODULE 92518 manufactured by Spacelabs Healthcare Inc..
[5238475]
Spacelabs received a report that a patient in the operating room? Turned blue? And coincidentally the oxygen readings were delayed from the multigas analyzers model 92518 which are connected to the command modules model 91496 and xprezzon patient monitors model 91393 that are in use. This spacelabs equipment is interfaced to datex omeda anesthesia carts aestiva 3000. No injury was reported as the result of the event which occurred on (b)(6), 2014.
Patient Sequence No: 1, Text Type: D, B5
[12651029]
A spacelabs field service engineer was dispatched to the customer site on (b)(4) 2014 to initiate an investigation. All spacelabs equipment used on the anesthesia carts was functionally tested and calibrated. However, the customer could not identify which unit was involved in the event and all equipment continues to be in service without further incident. Spacelabs continues to investigate this event and will file a follow up report when the investigation is concluded. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[34414431]
A spacelabs field service engineer (fse) was dispatched to the customer site to initiate an investigation. The customer could not identify which unit was involved in the event. As part of planned routine maintenance, all spacelabs equipment used on the anesthesia carts was functionally tested and calibrated by the fse. No issue was found with any of the equipment. The fse found that the customer was using non-spacelabs supplied accessory tubing for gas sampling that was wider and longer than the approved spacelabs accessory tubing. The spacelabs user manual identifies that spacelabs sample lines must be used with the spacelabs product, as use of other sample lines may cause inaccurate readings or results. The customer was informed this unapproved tubing could cause the delay in oxygen readings that the customer had experienced, and was advised to use the recommended spacelabs tubing. This report is final and the issue considered closed.
Patient Sequence No: 1, Text Type: N, H10
[34414432]
Spacelabs received a report that a patient in an operating room "turned blue" on (b)(6) 2014. Coincidentally, the oxygen readings were delayed from the multigas analyzers model 92518, which are connected to the command modules model 91496 and xprezzon patient monitors model 91393 that are used in the operating rooms. This spacelabs equipment is interfaced to datex omeda anesthesia carts model aestiva 3000. No injury was reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010157426-2014-00081 |
| MDR Report Key | 4378075 |
| Report Source | 05 |
| Date Received | 2015-01-02 |
| Date of Report | 2015-03-04 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2014-12-04 |
| Date Added to Maude | 2015-01-20 |
| 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 | MR. JOHN ZENG |
| Manufacturer Street | 35301 SE CENTER ST. |
| Manufacturer City | SNOQUALMIE WA 98065 |
| Manufacturer Country | US |
| Manufacturer Postal | 98065 |
| Manufacturer Phone | 4253635915 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACELABS MULTIGAS MODULE |
| Generic Name | MULTIGAS ANALYZER |
| Product Code | CBR |
| Date Received | 2015-01-02 |
| Model Number | 92518 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS HEALTHCARE INC. |
| Manufacturer Address | 35301 SE CENTER ST. SNOQUALMIE 98065 98065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-02 |