MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for CRITICAL ALERT / INTEGO 5430 manufactured by Critical Alert Inc. (formerly Wescom).
[72741224]
Patient Sequence No: 1, Text Type: N, H10
[72741225]
Our facility has critical alert/intego nurse call throughout the hospital. Much of the equipment was installed over four years ago. Patient stations fail from time to time and are replaced with new ones ordered from the company. A couple of months back we had some issues with the patient bed wall backlighting. It would come on and turn off intermittently throughout the day and night. After extensive troubleshooting and research we found that critical alert made a change to the electrical design of the patient station removing an internal ground in favor of an external ground tying a common ground to the nurse call patient station. This change was not communicated with the field and as a result it caused many patients undue stress and many lost man hours tracking down the particular cause. There was one instance where the patient had a history of epilepsy and the lighting portion of the system had to be completely disabled. No known patient harm occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6489484 |
| MDR Report Key | 6489484 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-03-20 |
| Report Date | 2017-04-10 |
| Date Reported to FDA | 2017-04-10 |
| Date Reported to Mfgr | 2017-04-10 |
| Date Added to Maude | 2017-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | CRITICAL ALERT / INTEGO |
| Generic Name | SYSTEM, COMMUNICATION, POWERED |
| Product Code | ILQ |
| Date Received | 2017-04-13 |
| Model Number | 5430 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITICAL ALERT INC. (FORMERLY WESCOM) |
| Manufacturer Address | 5343 BOWDEN RD. JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |