MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-22 for AVERY I-110A manufactured by Avery Biomedical Devices.
[1054566]
Prior to device failure, the patient was weaned from the ventilator using bilateral diaphragmatic pacers. The right pacer failed. By history from the patient's mother, the pacer was hit against the patient's wheelchair and subsequently stopped working. The patient was then placed back on the ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010852 |
| MDR Report Key | 1367928 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-04-10 |
| Date of Event | 2009-03-04 |
| Date Added to Maude | 2009-05-06 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVERY |
| Generic Name | I-110A RECEIVER; AVERY DIAPHRAGMATIC PACER |
| Product Code | GZE |
| Date Received | 2009-04-22 |
| Returned To Mfg | 2009-04-09 |
| Model Number | I-110A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVERY BIOMEDICAL DEVICES |
| Manufacturer Address | COMMACK NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-22 |