MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-06 for SUNQUEST COPATHPLUS manufactured by Sunquest Information System.
[4577630]
While using the copathplus quick sign-out reports feature, if a user presses the keyboard shortcut "crl-z" while editing text in a diagnostic text field, portions of previously saved text may disppear upon saving the report. While using the copathplus quick sign-out reports feature, if a user presses the keypad shortcut "ctrl o" the application may close unexpectedly.
Patient Sequence No: 1, Text Type: D, B5
[12154058]
Fourteen sites have been notified via product safety notice (psn) and a correction will be available in copathplus version 6. 1. 1 and above. There are 0 sites that have already been corrected. Steps to reproduce: logon as sunquest user and accession a surgical specimen. Navigate to the electronic signout for final report window for the specimen. Enter a large amount of text in the final diagnosis field and then click on save/quick sign/out to open the quick sign out report. Add some text to the first paragraph of the final diagnosis textfield and click ctrl-z to undo these additions. Click on edit specimen and then on ok to save changes. On returning to the electronic signout for final report notice that the first paragraph of the diagnosis is missing. Click on save/quick sign/out to open the quick sign out report. Click ctr-o and a system error window is displayed. If the user click ok then the copath application closes down.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2029302-2014-00001 |
| MDR Report Key | 3938587 |
| Report Source | 06 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-03-05 |
| Date of Event | 2014-02-10 |
| Date Mfgr Received | 2014-02-10 |
| Device Manufacturer Date | 2013-09-20 |
| Date Added to Maude | 2014-07-28 |
| 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 | PATRICE NEDELEC, VP CLIENT EXPER |
| Manufacturer Street | 250 S. WILLIAMS BLVD |
| Manufacturer City | TUCSON AZ 85711 |
| Manufacturer Country | US |
| Manufacturer Postal | 85711 |
| Manufacturer Phone | 5205702317 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNQUEST COPATHPLUS |
| Generic Name | COPATHPLUS |
| Product Code | NVV |
| Date Received | 2014-03-06 |
| ID Number | VERSION 6.1 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNQUEST INFORMATION SYSTEM |
| Manufacturer Address | 250 S. WILLIAMS BLVD TUCSON AZ 85711 US 85711 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-06 |