MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-29 for ENDOTOOL IV IV SOFTWARE VERSIONS 1.8.5 AND HIGHER manufactured by Monarch Medical Technologies.
[146484051]
All affected customer sites have been notified of the software bug. A patch was created and validated for endotool iv versions 1. 8. 5 and higher. The affected customer sites are being upgraded.
Patient Sequence No: 1, Text Type: N, H10
[146484052]
A software bug was discovered in endotool iv version 1. 10. This bug is in an area of the software that addresses persistently elevated glucose levels. Investigation and analysis of the bug has determined it is very unlikely to re-occur. In the very unlikely event it does re-occur, it could cause the software to incorrectly calculate an insulin dose recommendation. Investigation determined there has been only one occurence of the bug. The dose recommendation was correctly not accepted by the bedside caregiver and there was no associated patient harm. All affected customer sites have been notified of the software bug. A patch was created and validated for endotool iv versions 1. 8. 5 and higher. The affected customer sites are being upgraded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009864844-2019-00001 |
| MDR Report Key | 8649269 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-29 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2019-05-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRUCE LISANTI |
| Manufacturer Street | 2137 SOUTH BLVD. SUITE 300 |
| Manufacturer City | CHARLOTTE NC 28203 |
| Manufacturer Country | US |
| Manufacturer Postal | 28203 |
| Manufacturer Phone | 8553637475 |
| Manufacturer G1 | MONARCH MEDICAL TECHNOLOGIES |
| Manufacturer Street | 2137 SOUTH BLVD SUITE 300 |
| Manufacturer City | CHARLOTTE NC 28203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28203 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | 3009864844-5/9/2019-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTOOL IV |
| Generic Name | ENDOTOOL IV |
| Product Code | NDC |
| Date Received | 2019-05-29 |
| Model Number | IV SOFTWARE VERSIONS 1.8.5 AND HIGHER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONARCH MEDICAL TECHNOLOGIES |
| Manufacturer Address | 2137 SOUTH BLVD. SUITE 300 CHARLOTTE NC 28203 US 28203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |