MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-10-21 for MATTRESS COVER FOR MEDICAL PURPOSES CG9701 manufactured by Grand Healthcare Co., Ltd..
[5027389]
Ben states that he is not for sure that the pump is at fault. Will wait for patient to come in and test the unit and call back. Pump was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-04968 |
| MDR Report Key | 4187515 |
| Report Source | * |
| Date Received | 2014-10-21 |
| Date of Report | 2014-09-26 |
| Date Facility Aware | 2014-09-26 |
| Report Date | 2014-10-21 |
| Date Reported to FDA | 2014-10-21 |
| Date Reported to Mfgr | 2014-10-21 |
| Date Added to Maude | 2014-10-21 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATTRESS COVER FOR MEDICAL PURPOSES |
| Generic Name | 880.6190 |
| Product Code | FMW |
| Date Received | 2014-10-21 |
| Model Number | CG9701 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRAND HEALTHCARE CO., LTD. |
| Manufacturer Address | 4F, NO. 49, SEC.2 JEN AI ROAD TAIPEI TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-21 |