MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-19 for VOCERA COMMUNICATION DEVICE manufactured by Vocera Communication.
[86976417]
Our facility is using vocera: (b)(6) united states. This device has a strong magnetic field. It was interfering with our programmable shunt, strata, medtronic setting. Vocera are worn near the neck by health care professional and serve as a direct, secure communication device between health care professionals. For young kids, it is a routine practice that nurse are holding the child in their arms while they are bottle feeding them. The strong magnetic field of vocera was changing the setting in these patients. When we put the magnet locator of the strata shunt near the vocera, even when the battery was not in it, still changing the setting. So, our biomedical engineer thinks that the speaker magnet in the vocera is the problem. Strata shunts and other programmable shunts by themselves has no problem. Most of the pediatrics hospital around the country using this shunt. Many children's hospital are also using the vocera system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072226 |
| MDR Report Key | 6879312 |
| Date Received | 2017-09-19 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-09-17 |
| Date Added to Maude | 2017-09-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VOCERA COMMUNICATION DEVICE |
| Generic Name | VOCERA |
| Product Code | MSX |
| Date Received | 2017-09-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOCERA COMMUNICATION |
| Manufacturer Address | SAN JOSE CA 95126 US 95126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-19 |