MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-28 for CARDIOBEEPER CB12/12 * manufactured by Regus House.
[347711]
The cardiobeeper cb12/12 was cleared to market on july 2000 cardiobeeper cb12/12 koo2310. The device is used to transmit 12 lead ecg over the phone to a remote location/doctor's clinic. During the year 2001, the manufacturer of the device meridian medical technologies and the distributor of the device shl telemedicine int. Had found that the device is duplicating 4 out of the 12 leads it transmits and as so caused to misleading interpretation of the ecg by the doctors who received it and could lead to a serious safety problem and affect the functionality of the device. Although the severity of the malfunction was discovered and investigated, nothing was done to keep the safety of the pt who used this device at that time. During the year 2002 and 2003 shl telemedicine had replaced all the units that were at the market at that time total of 2500-3000 units with a new device, during this process they didn't notify the pts who had been using that device for that problem, nor notify the fda for the problem or the solution they implemented in the new device nor for the recall they made, moreover, they continue to sell the old device as usual till the time they finish to replace all the units in the market and in their warehouse. Documents and samples of both types of the devices that can support the above findings are available if required.
Patient Sequence No: 1, Text Type: D, B5
[397128]
Add'l info rec'd from mfr 3/24/05: a1. Cardiobeeper cb12/12. A trans-telephonic ecg monitor that is made exclusively for shl telemedicine international, based in tel aviv. The product is sold in israel and some european countries. A2. Not known as neither this info nor the device have been furnished. However, the narrative of the event on the medwatch form indicates that the device is of a mark 1 build standard. There was only one report made by shl in april 2001 of this repetition of traces in v4, v5 & v6 electrode traces. As part of our vigilance procedure, we proactively ask shl about the performance of our products every six months. There have been no further reports of such an event with either the mark 1 or mark 2 versions of the cb12/12. A4. The device was not returned for examination. No reasonable failure mode of the electronics to cause repetition of the v4, v5 & v6 electrode traces could be postulated. Extensive practical testing found that prolonged drenching of the electrode surfaces on the body belt could cause moisture absorption into the surface layers of the belt. This could in turn cause the electrical signals from an electrode to short through to adjacent tracks. This possible failure mode was not permanent, if the electrode belt was allowed to dry out, normal signal patterns returned. Shl were advised of these results and agreed to the proposed revision of the layout of the electrode belt. There had been only one report of this type of incident, however the advice given to shl's trainers (who instruct users in the correct use of the device)by shl development staff was changed to guard against excessive use of water by the user when trying to get a good electrode contact. The electrode belt changes were included in the general ease of use improvement programme that was already under way. Once the all the ease of use improvements had been developed, it was felt that the electrode contact had improved so much that there should be no need to wet the electrode surfaces. Thus, for the mark 2 device, the user leaflet had any reference to wetting the electrode surfaces removed. A6. Not explicitly stated, but most likely sometime between july 2000 and april 2001. A7. April 2001. A8. No person died or was injured as a result of the event described in the medical device report. It is the opinion of the firm that the event was not hazardous as although the person using the device isnot a healthcare professional, the data is reviewed by a healtcare professional at the call centre. The effect of this event was to duplicate the v4, v5 and v6 electrode traces. This would have been evident to medical staff as it would not have shown the expected "r wave progression". Such an event would therefore, degrade the info rather than dangerously corrupting it. A9. The device has not been specifically returned to the manufacturer. Shl have returned most cb12/12 mk1 devices for upgrading to mark 2 standard. In summary: this product is made exclusively for shl. The medwatch report was filed in jan. 2005 for an event that was notified to the company by shl in april 2001. The event was not hazardous in the opinion of the company, as the corruption of the data is evident to the shl healthcare professional that reviews the data. Thus, the data is degraded rather than dangerously corrupted. A modification to the electrode tracks layout was incorporated into an ease of use improvement programme that was already underway. The revised layout put a larger separation gap between adjacent electrodes tracks to reduce the likelihood of moisture absorption bridging the gap. There have been no further events of this nature notified t the company by shl. The company proactively canvasses for comments from shl every 6 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034520 |
| MDR Report Key | 571329 |
| Date Received | 2005-02-02 |
| Date of Report | 2005-01-28 |
| Date Added to Maude | 2005-02-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOBEEPER CB12/12 |
| Generic Name | 12 LEAD ECG TRANSMITTER |
| Product Code | DXH |
| Date Received | 2005-01-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 561177 |
| Manufacturer | REGUS HOUSE |
| Manufacturer Address | 33, CLARENDON DOCK BELFAST IS BT1 3BG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-02-02 |