MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-28 for SMARTSCREENER-PLUS2 M998920 manufactured by Intelligent Hearing Systems.
[132383846]
Only manufacturer authorized personnel must be used to repair the equipment. The instructions for use for the device state the following: defective components must not be used; and that broken, worn, or missing parts should be replaced promptly with new parts from the manufacturer; if operator believes that any part of the equipment is defective to contact the manufacturer. If the product is need of repair, do not use it until all repairs are completed, the unit is functioning properly and is appropriately tested. The owner of this product has sole responsibility for the following: maintenance or repairs done by anyone other than ihs authorized personnel, any malfunction caused by parts that are damaged or modified by anyone other than manufacturer authorized personnel. At the time of this report, the manufacturer has not received the damaged component from the field. The manufacturer simulated the scenario with another cart it had in inventory on 11/30/2018, but found the cart to remain stable with the same wheel that was reported to be defective removed. The manufacturer could not get the cart to tip over without physically pulling on the cart. The return of the damaged components have been requested from the field and a followup report will be sent after they are received and evaluated.
Patient Sequence No: 1, Text Type: N, H10
[132383847]
The manufacturer was informed by the equipment operator that the wheel on the equipment cart had fallen off out in the hospital hallway. The operator stated that she had placed the wheel back into the socket on the cart in order to be able to get the cart into an office. According to the operator, because the wheel was not thoroughly in place, she figured once the cart was back in the office, the operator could try and fix it. As a result of the wheel not being in place, the operator stated that the cart was not sturdy and that she had to lift/carry the cart while transporting the cart to the office. The operator stated that once she got to the office the wheel fell off again due to the carpet in the office that she had to roll over to enter the office. Then the operator placed the cart in the corner of the office and sat on the floor to figure out what was the cause of the wheel falling off and that the operator wanted to fix the problem as she wanted to resume using the equipment. The operator stated that while she was sitting on the floor examining the wheel, the cart tipped over on top of her. The operator stated she was definitely touching the cart, feeling the hole where the wheel goes, and examining the socket/ hole but does not recall if the cart fell while she was touching the cart. The operator states she was not pulling or pushing the cart while the wheel was off of it. The operator was advised by her employer to seek medical attention, which the operator declined to do. The operator stated she was not injured as a result of the cart tipping over. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000113738-2018-00001 |
| MDR Report Key | 8202712 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2009-10-07 |
| Date Added to Maude | 2018-12-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VICTOR HERNANDEZ |
| Manufacturer Street | 6860 SW 81ST ST |
| Manufacturer City | MIAMI FL 33143 |
| Manufacturer Country | US |
| Manufacturer Postal | 33143 |
| Manufacturer Phone | 3056686102 |
| Manufacturer G1 | INTELLIGENT HEARING SYSTEMS |
| Manufacturer Street | 6860 SW 81 ST |
| Manufacturer City | MIAMI FL 33143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33143 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTSCREENER-PLUS2 |
| Generic Name | AUTOMATED HEARING SCREENER |
| Product Code | GWJ |
| Date Received | 2018-12-28 |
| Model Number | M998920 |
| Catalog Number | M998920 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTELLIGENT HEARING SYSTEMS |
| Manufacturer Address | 6860 SW 81ST ST MIAMI FL 33143 US 33143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-28 |