MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-07 for EP-WORKMATE? AND WORKMATE? CLARIS? EP-4? TOUCHSCREEN COMPUTER 100056164 manufactured by St. Jude Medical, Inc..
[94109382]
During the procedure no response to input leading to a cancelled procedure occurred. When selecting f5 or f8 functions on the touchscreen there was no response and the menu screen would appear. An error message would also intermittently display on the touchscreen. Changing fiber cables and converters did not resolve the issue and the procedure was cancelled. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[108917818]
Patient Sequence No: 1, Text Type: N, H10
[109555952]
An event of no response to input and an error message resulting in a procedure cancellation was reported. Based on the information provided to abbott and the investigation performed, the root cause of the reported cancellation cannot be conclusively determined as no abnormalities were identified. The returned product operated as intended during the functional testing performed. The standard screen calibration confirmed that the touchscreen responded to tactile inputs as expected. The touchscreen did not exhibit noticeable delay or unexpected error messages during the serial port communication test. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2017-00071 |
| MDR Report Key | 7095697 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-07 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2014-03-28 |
| Date Added to Maude | 2017-12-07 |
| 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 | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP-WORKMATE? AND WORKMATE? CLARIS? EP-4? TOUCHSCREEN COMPUTER |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2017-12-07 |
| Model Number | 100056164 |
| ID Number | 05414734219112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-07 |