MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-03-21 for PRECISION FLOW PF-UNIT PF-UNIT-IT manufactured by Vapotherm, Inc..
[3392272]
A precision flow unit in italy was reported to have been experiencing flow rates that were higher than the dialed in setting. The high flows could continue for up to 15 seconds before a general fault alarm would be triggered. There were no pt injuries as a result however 15 seconds of higher than desired flow rates could potentially contribute to a pt injury if it were to occur again. The blocked tube alarm is designed to prevent the flow rate from increasing more than 10% above the dialed in flow rate. However, in this case the block tube alarm function had been turned off during a previous servicing of the device at a service center selected by the distributor. This function should have been turned back on prior to sending the unit back to the customer but the process step was missed by the service technician. It should be noted that it is not possible to turn all alarm functions off. The service center has modified their procedures and a capa has been initiated by the manufacturer to prevent this error from happening again.
Patient Sequence No: 1, Text Type: D, B5
[10602268]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1125759-2013-00001 |
| MDR Report Key | 3057512 |
| Report Source | 08 |
| Date Received | 2013-03-21 |
| Date of Report | 2013-03-21 |
| Date of Event | 2013-01-30 |
| Date Mfgr Received | 2013-02-21 |
| Date Added to Maude | 2013-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 198 LOG CANOE CIRCLE |
| Manufacturer City | STEVENSVILLE MD 21666 |
| Manufacturer Country | US |
| Manufacturer Postal | 21666 |
| Manufacturer Phone | 4106040808 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION FLOW |
| Generic Name | PRECISION FLOW |
| Product Code | CAX |
| Date Received | 2013-03-21 |
| Model Number | PF-UNIT |
| Catalog Number | PF-UNIT-IT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VAPOTHERM, INC. |
| Manufacturer Address | STEVENSVILLE MD 21666 US 21666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-21 |