MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-08 for MIDMARK 625-001 manufactured by Midmark Corporation.
[69437793]
A biomedical engineer staff member of the user facility attempted to duplicate the identified issue, but was unsuccessful. Additionally, a certified midmark technician was sent to the user facility where he was also unable to duplicate the issue, and also verified the device was operating as intended.
Patient Sequence No: 1, Text Type: N, H10
[69437794]
While in the lowest position (approximately 18 inches from the floor to the table top) the table moved unexpectedly in the up direction, causing a (b)(6) year old female patient to panic, jumping off the table without warning to the provider (aka unassisted), who was not in a position to be able to stop the patient, and breaking her arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2017-00002 |
| MDR Report Key | 6388836 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-08 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-03-08 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM CLUTTER |
| Manufacturer Street | 60 VISTA DRIVE |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268474 |
| Manufacturer G1 | MIDMARK CORPORATION |
| Manufacturer Street | 60 VISTA DRIVE |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | 625 BARRIER-FREE EXAMINATION TABLE |
| Product Code | LGX |
| Date Received | 2017-03-08 |
| Model Number | 625-001 |
| Catalog Number | 625-001 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 60 VISTA DRIVE VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-08 |