MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-30 for VITAL SYNC REMOTE MONITORING SYSTEM 10116080 manufactured by Avnet Inc.
[185600978]
(b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185600979]
According to the reporter, the patient died on (b)(6) 2020 and the device had not alarmed and presented the error message "no data for reported parameter". In a follow up phone conversation (b)(6) 2020 with the hospital technician it was clarified that the nurse manager of the orthopedic unit/floor was attempting to gather patient data but was unable to. The tech support team was able to find alarm reports for the dates of (b)(6) 2020 to (b)(6) 2020, but there was no information after that. The vital sync system showed that the patient was "discharged" by a nurse on (b)(6) 2020. They do not believe that the vital sync malfunctioned in any way since the patient was discharged from the vital sync system days prior to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00234 |
| MDR Report Key | 9900478 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI LUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | AVNET INC |
| Manufacturer Street | 2740 AMERICAN BLVD W, STE 150 |
| Manufacturer City | BLOOMINGTON MN 55431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SYNC REMOTE MONITORING SYSTEM |
| Generic Name | TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY |
| Product Code | DRG |
| Date Received | 2020-03-30 |
| Model Number | 10116080 |
| Catalog Number | 10116080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVNET INC |
| Manufacturer Address | 2740 AMERICAN BLVD W, STE 150 BLOOMINGTON MN 55431 US 55431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-30 |