MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-13 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.
[179415545]
Product analysis: analysis of the logs was able to confirm the report that the programmer application closed when triggering the high gain mode under waveform settings. It was confirmed that the malfunction was a result of a known documented issue that was under investigation by the company. It is believed that a fix for the issue was implemented in the next application software version update. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179415546]
It was reported that the programmer application closed and returned to the home screen when attempting to turn on the highgain mode in the analyzer settings. It was noted that connection between the base and patient connector were also lost. After reestablishing connection and staring up the analyzer it showed that highgain mode was on. The application shut down again upon turning the mode off. The issue was escalated for investigation into the root cause. The programmer and application remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004593495-2020-00147 |
| MDR Report Key | 9708133 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| Model Number | 24970A |
| Catalog Number | 24970A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-13 |