MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for EASY GO VAC ASPIRATOR manufactured by Precision Medical.
[83971864]
Reporter is reporting on behalf of her husband who has a stage four cancer and has a tracheostomy which needed to be suctioned. Two precision medical machines were delivered for suctioning. At the time of delivery there were no instructions on how to use the machines and her husband was not home to try the machines himself. Reporter called the suppliers and they promised to send an email with the instructions but the email was never received. Reporter stated these machines are not operational since there are no instructions. One of the machines the easy air compressor cup fell off the machine and they could not put it back together because there are no instructions on how to use or fix it. A service call was placed for replacement of the suction cup but they could not put it together or operate the machine. They are still experiencing problems with these machines. She believes it is a scam since the delivery person keep coming to her house with the pretence of delivering parts of these machines but the machines are still non operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071814 |
| MDR Report Key | 6826751 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-08-26 |
| Date Added to Maude | 2017-08-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EASY GO VAC ASPIRATOR |
| Generic Name | EASY GO VAC ASPIRATOR |
| Product Code | BTA |
| Date Received | 2017-08-29 |
| ID Number | ITEM ID #E0600 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Brand Name | EASY AIR COMPRESSOR |
| Generic Name | EASY AIR COMPRESSOR (HUMIDIFIER) |
| Product Code | BTI |
| Date Received | 2017-08-29 |
| ID Number | ITEM ID #E0565 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |