MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-08-16 for IFLOW IFLOW 200 S PROXIMAL FLOW SENSOR 301.328.010 manufactured by Imtmedical Ag.
[154626952]
Any additional information received from the customer will be included in a follow-up report. Technical support in conjunction with the customer reported alarm 274 - "flow measured proximally is greater than the flow delivered" with 3 pc. Iflow 200 s of batch 4716 even if the circuit system test was successful. So total of affected sensors is 3 pc. Also, they had to switch to bag ventilation while exchanging the proximal flow sensor.
Patient Sequence No: 1, Text Type: N, H10
[154626953]
Customer reported alarm 274 - flow measured proximally is greater than the flow delivered. There were 3 pieces sensors affected the iflow 200 s of batch 4716 even if the circuit system test was successful. Customer confirmed that the patient was switch to a manual resuscitation bag while exchanging the proximal flow sensor. There was a patient involvement but no harm and no medical intervention occurred in this reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013407532-2019-00001 |
| MDR Report Key | 8902818 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-08-16 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Date Added to Maude | 2019-08-16 |
| 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 | 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 | 2019-08-16 |
| Model Number | IFLOW 200 S PROXIMAL FLOW SENSOR |
| Catalog Number | 301.328.010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMTMEDICAL AG |
| Manufacturer Address | 10 JALAN KILANG SIME DARBY ENTERPRISE CENTRE#06-06 SINGAPORE, 15941 SN 15941 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-16 |