MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-04 for WATER PERFUSION MANOMETRY SQ15000805 NA manufactured by Mms.
[5941571]
Armdorfer and mms water perfusion manometry system has inadequate cleaning instructions. These devices were manufactured prior to 1976 and the cleaning instructions do not hold up to todays standards. These units are still in use throughout many hospitals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043025 |
| MDR Report Key | 4834873 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-04 |
| Date of Event | 2015-06-01 |
| Date Added to Maude | 2015-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER PERFUSION MANOMETRY |
| Generic Name | WATER PERFUSION MANOMETRY |
| Product Code | FFX |
| Date Received | 2015-06-04 |
| Model Number | SQ15000805 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Expiration Date | 2015-06-01 |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMS |
| Brand Name | WATER PERFUSION MANOMETRY |
| Generic Name | WATER PERFUSION MANOMETRY |
| Product Code | KLA |
| Date Received | 2015-06-04 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ARNDORFER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-04 |