MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-11-16 for MARUS MAXSTAR NARROW BACK HYDRAULIC CHAIR DC1690-115 manufactured by Dental Equipment, Llc (dba Newberg Manufacturing).
[750918]
It was reported that both the left and right back rest bolts on a dc 1690 dental chair backed out at the same time causing the back rest to fall down towards the floor with a patient in the chair, however, the dental assistant happened to be behind the chair at this time and caught the chair back before it fell back down towards the floor. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[8009702]
According to the dental office manager, the dealer technician replaced both the left and right bolts on the chair back assembly. The chair is not operating within factory specifications. We tried contacting the distributor on numerous occasions, including mailing a certified letter, however, the distributor never called us back. We wanted to get a better understanding of how both bolts could have simultaneously backed out at the same time. The chair has already been repaired so we are unable to determine the cause of failure since we don't have the bolts he replaced. This is the first time we have become aware of a complaint of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004517290-2007-00004 |
| MDR Report Key | 949587 |
| Report Source | 08 |
| Date Received | 2007-11-16 |
| Date of Report | 2007-10-25 |
| Date of Event | 2007-10-24 |
| Date Mfgr Received | 2007-10-25 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2008-01-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY, MGR |
| Manufacturer Street | 11727 FRUEHAUF DR |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING) |
| Manufacturer Street | 705 S. SPRINGBROOK RD. SUITE B200 |
| Manufacturer City | NEWBERG OR 97132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97132 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARUS MAXSTAR NARROW BACK HYDRAULIC CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2007-11-16 |
| Model Number | DC1690-115 |
| Catalog Number | DC1690-115 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 948908 |
| Manufacturer | DENTAL EQUIPMENT, LLC (DBA NEWBERG MANUFACTURING) |
| Manufacturer Address | 705 S. SPRINGBROOK RD. SUITE B200 NEWBERG OR 97132 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-16 |