MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for TELEMETRY manufactured by Spacelabs.
[89630385]
Patient Sequence No: 1, Text Type: N, H10
[89630386]
When the spacelabs central stations are being serviced or down due to technical issues, telemetry reporting to the central station is lost and there is no way to "replay" the telemetry history. The concern is that the central monitoring isn't available for a period of time and there is no way to go back and retrospectively review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6957756 |
| MDR Report Key | 6957756 |
| Date Received | 2017-10-18 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-08-19 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-10-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TELEMETRY |
| Product Code | MSX |
| Date Received | 2017-10-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS |
| Manufacturer Address | 35301 SE CENTER ST SNOQUALMIE WA 98065 US 98065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-18 |