MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-02-15 for PRISMAFLO II PF2-265NA manufactured by Stihler Electronic Gmbh.
[139328243]
Further investigations are not possible as the defective device was not available for investigation and s/n of defective device was not transmitted. From the event description the device reacted with an alarm and heater cut off as intended. Should additional relevant information become available a supplement report will be submitted. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[139328244]
It was reported when the prismaflo ii was turned on, it was continuously beeping. After pressing the start button it started flashing e26. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617473-2018-00008 |
| MDR Report Key | 8342361 |
| Report Source | OTHER |
| Date Received | 2019-02-15 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2019-02-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL SCHELLING |
| Manufacturer Street | JULIUS-HOELDER-STRASSE 36 |
| Manufacturer City | STUTTGART, 70597 |
| Manufacturer Country | GM |
| Manufacturer Postal | 70597 |
| Manufacturer G1 | STIHLER ELECTRONIC GMBH |
| Manufacturer Street | JULIUS-HOELDER-STRASSE 36 |
| Manufacturer City | STUTTGART, 70597 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 70597 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLO II |
| Generic Name | BLOOD WARMER |
| Product Code | KOC |
| Date Received | 2019-02-15 |
| Model Number | PF2-265NA |
| Catalog Number | PF2-265NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIHLER ELECTRONIC GMBH |
| Manufacturer Address | JULIUS-HOELDER-STRASSE 36 STUTTGART, 70597 GM 70597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |