MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-13 for ZERO-GRAVITY ZGM-6-5H manufactured by Tidi Products, Llc.
[62217880]
Patient Sequence No: 1, Text Type: N, H10
[62217881]
Zero gravity suspended radiation protection device broke during ablation procedure. Patient was on table and the device fell into doctor, hitting him in the head and the weight of lead device falling on both arms and shoulders. Manufacturer response for lead apron, zero gravity (per site reporter): they replaced the unit and took ours back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6169401 |
| MDR Report Key | 6169401 |
| Date Received | 2016-12-13 |
| Date of Report | 2016-10-24 |
| Date of Event | 2016-07-29 |
| Report Date | 2016-10-24 |
| Date Reported to FDA | 2016-10-24 |
| Date Reported to Mfgr | 2016-10-24 |
| Date Added to Maude | 2016-12-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | BIOMEDICAL ENGINEER |
| 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 | 3 |
| Brand Name | ZERO-GRAVITY |
| Generic Name | APRON, LEADED |
| Product Code | EAJ |
| Date Received | 2016-12-13 |
| Returned To Mfg | 2016-08-02 |
| Model Number | ZGM-6-5H |
| ID Number | 559430-L-02 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 14241 N. FENTON RD. FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-13 |