MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-04-13 for SPACELABS MULTIGAS ANALYZER MODULE 91518 manufactured by Spacelabs Medical Inc..
[2589389]
Spacelabs received a report that a multigas analyzer module had no fio2 display on the screen.
Patient Sequence No: 1, Text Type: D, B5
[3273012]
Spacelabs received a report that a multigas analyzer module had no fi02 display on the screen.
Patient Sequence No: 1, Text Type: D, B5
[9799555]
Spacelabs has requested the subject device to be returned for investigation. We are waiting to receive the device. We are also collecting more information from the distributor. 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
[10729314]
No one was injured as a result of this event. The customer corrected the complaint description saying the 91518 multigas analyzer failed to turn on. This condition precludes its use in a clinical procedure. Spacelabs replaced the suspect devices for this customer and have received no further reports of 91518 modules failing to turn on. Spacelabs considers this issue closed. The hospital only sent pcba's for evalua...
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2012-00016 |
| MDR Report Key | 2535718 |
| Report Source | 01,08 |
| Date Received | 2012-04-13 |
| Date of Report | 2013-04-23 |
| Date of Event | 2012-03-29 |
| Date Mfgr Received | 2012-03-29 |
| Device Manufacturer Date | 2011-12-27 |
| Date Added to Maude | 2012-09-11 |
| 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 ROB TEETER |
| Manufacturer Street | 35301 SE CENTER ST |
| Manufacturer City | SNOQUALMIE WA 98065 |
| Manufacturer Country | US |
| Manufacturer Postal | 98065 |
| Manufacturer Phone | 4253635915 |
| Manufacturer G1 | SPACELABS MEDICAL INC. |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98027701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98027 7018 |
| 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 | 2012-04-13 |
| Model Number | 91518 |
| Device Expiration Date | 2012-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-04-13 |