MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for MONARCH H6340 manufactured by Air Techniques Inc..
[109773336]
On 3/20/2018 product is currently being evaluated by supplier. Scar # (b)(4) was issued to supplier on 3/2/2018. On 5/25/2018 report was previously submitted on time with successful ack3s responses but on 5/23/2018 we noticed that the mfr report # on the original report was incorrect. We have corrected the mfr report # (2428225-2018-00002. ).
Patient Sequence No: 1, Text Type: N, H10
[109773337]
Office opened 2 bottles of line cleaner and noticed that there was mold in the bottles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2018-00002 |
| MDR Report Key | 7554707 |
| Date Received | 2018-05-30 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-02-21 |
| Report Date | 2018-02-22 |
| Date Reported to Mfgr | 2018-02-22 |
| Date Mfgr Received | 2018-02-21 |
| Date Added to Maude | 2018-05-30 |
| 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. JOSEPH LATKOWSKI |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5162145541 |
| Manufacturer G1 | AIR TECHNIQUES INC. |
| Manufacturer Street | AIR TECHNIQUES INC. 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONARCH |
| Generic Name | DISINFECTANT MEDICAL DEVICE |
| Product Code | LRJ |
| Date Received | 2018-05-30 |
| Returned To Mfg | 2018-03-09 |
| Model Number | H6340 |
| Catalog Number | H6340 |
| Lot Number | G289 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR TECHNIQUES INC. |
| Manufacturer Address | 1295 WALT WHITMAN ROAD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-30 |