MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-08-08 for MIDMARK 630-001 manufactured by Midmark Corp..
[2240957]
The tilt actuator on the table broke allowing the table top to tilt back. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[9455483]
The device was repaired by the hospital biomedical engineer and the tilt actuator was discarded before it could be returned for eval. Photographs of the actuator showed that the aluminum casting which holds the actuator to the base had broken it is not clear what caused the break.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2011-00024 |
| MDR Report Key | 2240909 |
| Report Source | 06,07 |
| Date Received | 2011-08-08 |
| Date of Report | 2011-08-08 |
| Date of Event | 2011-07-14 |
| Date Mfgr Received | 2011-07-14 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2011-10-28 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONALD CARR |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2011-08-08 |
| Model Number | 630-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-08 |