MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-24 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.
[176381295]
Product analysis : analysis confirmed original complaint. The behavior is linked to a known issue, rpi 108712. The interrogation hangs when initiated while the application is in background. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176381296]
It was reported that during use of an electrocautery device, the programmer had been placed on the cart next to the cautery machine. When the physician started using cautery, the programmer displayed a dotted line for the connection status. When cautery was turned off, the connection resumed. When the physician continued use of cautery, the application completely crashed and the home screen was displayed. In addition, when first pulling up the programmer, and trying to pair the patient connector, the application completely froze. A spinning hour glass displayed, and the application was frozen for five minutes. The user closed the application to restart. 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 | 3004593495-2020-00061 |
| MDR Report Key | 9629918 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-03-22 |
| Date Added to Maude | 2020-01-24 |
| 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 | 2020-01-24 |
| Model Number | 24970A |
| Catalog Number | 24970A |
| 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 | 2020-01-24 |