MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-04 for SPACELABS ULTRAVIEW SL COMMAND MODULE 91496 manufactured by Spacelabs Healthcare.
[16837387]
Spacelabs has received a report of significant noise observed on the ecg signal when other devices were energized in an operating room.
Patient Sequence No: 1, Text Type: D, B5
[16937991]
Spacelabs was able to confirm the reported symptoms at the customer's site. Spacelabs has worked with the customer to optimize the user setting and adjust cabling to minimize the interference. No one has been injured as a result of this condition. The hospital is continuing to use the equipment. The spacelabs investigation is on-going. We will provide a supplemental report once our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2010-00028 |
| MDR Report Key | 1827539 |
| Report Source | 05 |
| Date Received | 2010-09-04 |
| Date of Report | 2010-09-03 |
| Date of Event | 2010-08-05 |
| Date Mfgr Received | 2010-08-05 |
| Date Added to Maude | 2011-03-30 |
| 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 | DAVID GERAGHTY, MANAGER |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACELABS ULTRAVIEW SL COMMAND MODULE |
| Generic Name | MULTIPARAMETER MODULE |
| Product Code | LOS |
| Date Received | 2010-09-04 |
| Model Number | 91496 |
| 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 | 2010-09-04 |