MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-10 for SPACELABS CLINICAL ACCESS/ ICS manufactured by Spacelabs.
[82694256]
On a recently cardiac monitored patient's ecg record, the saved cardiac event time stamps did not match time stamps on overall strip review analysis. This is a known issue according to spacelabs when certain editing steps are taken in the software, yet the software does not prevent a user from taking the very steps which spacelabs tech support says should never be taken. Very serious documentation integrity issue that needs to be corrected by the manufacturer asap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071544 |
| MDR Report Key | 6791517 |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-28 |
| Date Added to Maude | 2017-08-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | SPACELABS CLINICAL ACCESS/ ICS |
| Generic Name | CLINICAL EVENT INTERFACE |
| Product Code | MSX |
| Date Received | 2017-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-10 |