ACHALASIA PNEUMATIC HAND PUMP AND MONITOR Adverse Event — Malfunction (MDR 3005099803-2008-00171)
ACHALASIA PNEUMATIC HAND PUMP AND MONITOR Adverse Event — Malfunction (MDR 3005099803-2008-00171) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACHALASIA PNEUMATIC HAND PUMP AND MONITOR; Generic name: GBA; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | ACHALASIA PNEUMATIC HAND PUMP AND MONITOR |
|---|---|
| Generic name | GBA |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2008-00171 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | NOTE: THE DATE OF EVENT UNK. ON JANUARY 22, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACHALASIA PNEUMATIC HAND PUMP AND MONITOR WAS TESTED PRIOR TO A PT'S PROCEDURE. ACCORDING TO THE COMPLAINANT, PRETESTING PERFORMED BY THE HOSP'S TECHNICAL DEPT. "THE PRESSURE IS 2 (TWICE) AS HIGH AS THE GAUGE SAYS. FOR EXAMPLE: WHEN THE UNITS SAYS THE PSI IS 10, IN REALITY THE PSI IS 20." THE |
| Source | openFDA MAUDE (device adverse events) |
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