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 2020-01-02 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.
[175553796]
Product analysis: analysis confirmed that when creating a portable document format (pdf) in the application and an attempt was made to send it to the universal serial bus (usb), by using "send to", the screen froze. According to the logs, an exception occurred while reopening the socket when the application came to the foreground. This is a known background foreground issue what was fixed with a new version. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175607398]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175607399]
It was further reported that the programmers screen had froze when saving the pdf to the usb in the mobile programmer application. After that, the application was rebooted, but the same event occurred twice. The pdf could be saved the third time.
Patient Sequence No: 1, Text Type: D, B5
[175653057]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175653058]
It was reported that there was incorrect programming/programming difficulty with the programmer. It was noted that the programmer screen froze by storing portable document format (pdf) in the universal serial bus (usb) memory stick when the mobile programmer application was run. The issue was attempted to be resolved by shutting down and rebooting the application, however the same event occurred twice. The issue was noted to resolve with a reboot. The programmer remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2020-00004 |
| MDR Report Key | 9538674 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-01-02 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Street | BAYAN LEPAS FREE INDUSTRIAL ZO |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARELINK SMARTSYNC BASE |
| Generic Name | ANALYZER, PACEMAKER GENERATOR FUNCTION |
| Product Code | DTC |
| Date Received | 2020-01-02 |
| Model Number | 24970A |
| Catalog Number | 24970A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Address | BAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |