MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-23 for VITAL SIGNS IN900012 manufactured by Hygia Health Services, Inc..
[63200991]
Patient Sequence No: 1, Text Type: N, H10
[63200992]
The pressure bag will not inflate. The bulb will not pump up. This is the second occurrence; the first one occurred about a month ago and the device involved in that event was sent to the company for evaluation. No report as of yet on the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6202083 |
| MDR Report Key | 6202083 |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-12-13 |
| Report Date | 2016-12-16 |
| Date Reported to FDA | 2016-12-16 |
| Date Reported to Mfgr | 2016-12-16 |
| Date Added to Maude | 2016-12-23 |
| 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 | VITAL SIGNS |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2016-12-23 |
| Model Number | IN900012 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGIA HEALTH SERVICES, INC. |
| Manufacturer Address | 11600 ADELMO LN FORT MAYERS FL 33966 US 33966 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-23 |