MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-28 for ALLIED HEALTHCARE PRODUCTS, INC. 15100 CAM 4 15100 manufactured by Allied Healthcare Products, Inc..
[49716]
When the mist tent is set-up per mfr's recommendations a static problem is present. With the unit properly set-up and running, if one holds the three outlet hoses in one hand and touches the equipment chasis with the other hand one will receive a static shock. This was duplicated by the mfr on site at hosp. Equipment was never used on pt. Mfr's attitude was that this problem was unique to this institution only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 77904 |
| MDR Report Key | 77904 |
| Date Received | 1997-02-28 |
| Date of Report | 1997-01-13 |
| Date of Event | 1996-11-15 |
| Date Facility Aware | 1996-11-15 |
| Report Date | 1997-01-13 |
| Date Reported to FDA | 1997-01-13 |
| Date Reported to Mfgr | 1997-01-13 |
| Date Added to Maude | 1997-03-26 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLIED HEALTHCARE PRODUCTS, INC. |
| Generic Name | O2/MIST TENT |
| Product Code | BYL |
| Date Received | 1997-02-28 |
| Model Number | 15100 CAM 4 |
| Catalog Number | 15100 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 77547 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. ST. LOUIS MO 631101927 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-28 |