MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-08-01 for ANALYZER, GAS, OXYGEN, GASEOUS-PHASE IRC400 manufactured by Dynamic Controls.
[4637163]
Per the dealer, the unit will not analyze.
Patient Sequence No: 1, Text Type: D, B5
[34479702]
(b)(4). Upon further review, it was determined that the initial report submitted on 08/01/2014 for manufacturer report # 9613440-2014-00001 was not a reportable event. This product, an irc400 hand held analyzer, is not a medical device. It is a technician's tool for oxygen concentrators to check the oxygen concentration, flow rate and outlet pressure. No mdr needed to be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613440-2014-00001 |
| MDR Report Key | 3973373 |
| Report Source | * |
| Date Received | 2014-08-01 |
| Date of Report | 2014-06-13 |
| Date Mfgr Received | 2014-06-13 |
| Date Added to Maude | 2014-08-13 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN LOUGHREN |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | DYNAMIC CONTROLS |
| Manufacturer Street | 17 PRINT PLACE |
| Manufacturer City | CHRISTCHURCH 8002 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 8002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Generic Name | 868.1720 |
| Product Code | CCL |
| Date Received | 2014-08-01 |
| Model Number | IRC400 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNAMIC CONTROLS |
| Manufacturer Address | 17 PRINT PLACE CHRISTCHURCH 8002 NZ 8002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-01 |