MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-26 for H2 EZ DEFLATE PRESSURE CUFF 7204012 manufactured by Smiths Medical Asd, Inc.
[181123901]
Evaluation results: one h2 ez deflate pressure cuff was returned for investigation in good but used condition. Visual inspection revealed that the h-2 pressure gauge needle was stuck at 110 mmhg. The customer reported product problem was therefore verified. The h-2 pressure gauge was replaced and the unit was calibrated. The unit passed all functional test following this. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event. The source of the problem was attributed to the supplier.
Patient Sequence No: 1, Text Type: N, H10
[181123902]
It was reported that during device preventive maintenance, the pressure gauge was reading over 100 mmhg even though there was no pressure. The gauge failed to return to 0. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01531 |
| MDR Report Key | 9753508 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2020-02-26 |
| 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 | 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 | H2 EZ DEFLATE PRESSURE CUFF |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2019-05-13 |
| Catalog Number | 7204012 |
| 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 | 2020-02-26 |