MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-09-06 for IFLOW IFLOW 40 S PROXIMAL FLOW SENSOR 301.470.010 manufactured by Imtmedical Ag.
[156896632]
Any additional information received from the customer will be included in a follow-up report. The suspected device's accessory was being used for several days until the reported issue occurred. Rough handling is not an issue after replacement of the flow sensor. At this time, there is no information regarding the log files of the device. The flow sensor is still under investigation. Therefore, no definitive root cause can be determined.
Patient Sequence No: 1, Text Type: N, H10
[156896633]
The customer reported defective/broken flow sensors. The device was alarming with "tidal volume high" while patient was stable. A whistling noise was heard and the breakline was identified at the flow sensor. The ventilation continue working as intended with no further alarm. The end user successfully replaced the flow sensor during ventilation on a patient. The issue resolved afterwards. There is no patient harm with this reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013407532-2019-00003 |
| MDR Report Key | 8972858 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-09-06 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-09-06 |
| 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 | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | TECHNOCOM SYSTEMS SDN BHD |
| Manufacturer Street | PLO 1 JALAN FIRMA 1 KAWASAN PERINDUSTRIAN TEBRAU 1 |
| Manufacturer City | JOHOR BAHRU, 81100 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 81100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IFLOW |
| Generic Name | SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) |
| Product Code | BZO |
| Date Received | 2019-09-06 |
| Model Number | IFLOW 40 S PROXIMAL FLOW SENSOR |
| Catalog Number | 301.470.010 |
| Lot Number | 1218 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMTMEDICAL AG |
| Manufacturer Address | 10 JALAN KILANG SIME DARBY SINGAPORE, 15941 SN 15941 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-06 |