MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-06 for EZ DEFLATE PRESSURE CUFF 7204017 manufactured by Smiths Medical Asd, Inc.
[182525379]
The event date is an approximate date. Only the month ((b)(6)) and year (2019) are known. Evaluation results: one ez deflate pressure cuff was returned for investigation. Upon visual inspection, the investigator observed that the pressure chamber had a loose hose. There was also a crack on the pressure chamber door. The unit was losing pressure due to the aforementioned reasons. The door was replaced and the loose tubing was adjusted. The ez deflate pressure cuff was subsequently connected to the one level 1 trauma fast flow system. The desired pressure of 289 mmhg was then achieved on the one level 1 trauma fast flow system. The customer reported product problem was therefore replicated. The problem source of the reported product problem was unknown. A root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[182525380]
It was reported pressure chambers infused only 60 percent of the infusion bag in five minutes. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01712 |
| MDR Report Key | 9802710 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-06-01 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2020-03-06 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ DEFLATE PRESSURE CUFF |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2019-08-13 |
| Catalog Number | 7204017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |