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 H1000 H-1000-GE-230 manufactured by Smiths Medical Asd, Inc.
[182522332]
The event date is an approximate date. Only the month ((b)(6) and year (2019) are known. Evaluation results: one level 1 trauma fast flow system (230 german h1000) was returned for investigation in used condition. When the unit was connected to the pressure chamber with serial number (sn) (b)(4), a pressure of 50 mmhg was noted. When the unit was connected to the pressure chamber with sn (b)(4), a pressure of 200 mmhg was noted. The pressure on the unit was then verified against a pressure gauge. The registered pressure for the unit was 262 mmhg. This pressure reading was below the expected normal pressure of 289 mmhg. The compressor was replaced. In addition repairs were made to the ez deflate pressure cuff accessories (please refer to 3012307300-2020-01711 and 3012307300-2020-01712). Following the aforementioned repairs, the unit registered the normal pressure of 289 mmhg. 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
[182522333]
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 | 3012307300-2020-01713 |
| MDR Report Key | 9802704 |
| 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 | 1999-05-05 |
| 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 |
| Model Number | H1000 |
| Catalog Number | H-1000-GE-230 |
| 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 |