MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-17 for UNIVERSAL CUFF COVER STANDARD SIZE 706-0182-00 manufactured by Spacelabs Healthcare Ltd..
| Report Number | 9611295-2020-00001 |
| MDR Report Key | 9602758 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-17 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID GERAGHTY |
| Manufacturer Street | 35301 SE CENTER ST. |
| Manufacturer City | SNOQUALMIE WA 98065 |
| Manufacturer Country | US |
| Manufacturer Postal | 98065 |
| Manufacturer Phone | 4253635889 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL CUFF COVER STANDARD SIZE |
| Generic Name | BLOOD PRESSURE CUFF COVER |
| Product Code | DXN |
| Date Received | 2020-01-17 |
| Catalog Number | 706-0182-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS HEALTHCARE LTD. |
| Manufacturer Address | UNIT B, FOXHOLES CENTRE JOHN TATE ROAD HERTFORD SG137DT UK SG137DT |
| Product Code | --- |
| Date Received | 2020-01-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |