MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-07-09 for RESPONDER 5 manufactured by Rauland-borg.
[4558749]
Rauland received a complaint that a code blue button failed to activate during an active code blue event. There was no pt/user injury resulting from the alleged code blue button malfunction. After the code event the hospital checked all 12 code stations in the icu and found one add'l code blue station that did not function. The hospital tech disconnected and reconnected the two stations involved which resulted in both code blue stations performing as intended. The root cause of this alleged malfunction was not determined. Two important factors have been confirmed. The hospital is undergoing construction, and the responder's system supervision feature which would have alerted hospital personnel of system issues (e. G. A power interrupt) was turned off. The nature of the alleged malfunction suggests possible incomplete re-connection of the affected code station equipment possibly related to ongoing construction, but we were unable to verify this during event reviews with the system installation vendor or hospital risk manager and facility tech. The installation vendor's service tech offered to replace both of the stations involved; the hospital, however, did not request replacements as the system is working as intended. Based on this info, no further action is required.
Patient Sequence No: 1, Text Type: D, B5
[12096458]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000227151-2014-00001 |
| MDR Report Key | 3959894 |
| Report Source | 08 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-07-09 |
| Date of Event | 2014-06-07 |
| Date Added to Maude | 2014-07-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONNA DIJINOVICH |
| Manufacturer Street | 1802 WEST CENTRAL ROAD |
| Manufacturer City | MOUNT PROSPECT IL 600562230 |
| Manufacturer Country | US |
| Manufacturer Postal | 600562230 |
| Manufacturer Phone | 8475907100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPONDER 5 |
| Generic Name | RESPONDER NURSE CALL SYSTEM |
| Product Code | IQA |
| Date Received | 2014-07-09 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAULAND-BORG |
| Manufacturer Address | 1802 WEST CENTRAL ROAD MOUNT PROSPECT IL 60056223 US 60056 2230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-09 |