MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-04-25 for MIDMARK 153592 manufactured by Midmark Corp..
[4401125]
The upper portion of chair came apart with pt in chair. The chair top tipped allowing the pt to fall to the floor. The pt reported stains from the movement.
Patient Sequence No: 1, Text Type: D, B5
[11899458]
An eval of the chair was done on-site and at our facility. The investigation found that the original chair back was replaced by another party. We were unable to locate records finding who performed this repair. Thru eval, we have confirmed that existing mounting instructions for replacing the chair back do include the use of loctite and torque specs for these bolts. We were unable to determine if the torque spec was ever met, but there was no evidence of loctite used. Abnormal wear marks showing the bolt threads cutting into the casting was noted on the left side of the chair back mounting. Investigations concluded that one bolt had backed out prior to this failure and was not detected for some time based on the appearance of the bolt. Servicing that was conducted by a non-midmark entity did not find this failure, although the customer did note that they detected something "wrong" with the unit prior to failure. At the time of this report, we have not been able to acquire the service records. The initial bolt backing out of the chair back caused add'l damage to the chair and ultimately lead to the failure of the second mounting point. The failure that occurred has been determined to be related to improper installation and servicing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2014-00009 |
| MDR Report Key | 3815010 |
| Report Source | 07,08 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-04-25 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-03-26 |
| Device Manufacturer Date | 2008-10-01 |
| Date Added to Maude | 2014-06-20 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG RAMMEL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK |
| Generic Name | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT |
| Product Code | NRU |
| Date Received | 2014-04-25 |
| Model Number | 153592 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-25 |