MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for SPIRIT 1700 CHAIR SP17 W1702 manufactured by Pelton & Crane.
[68514001]
The dental chair is in the process of being returned to pelton & crane. A follow-up report will be submitted upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[68514002]
It was reported by a pelton & crane distributor that a dental hygienist was reclining a patient in a pelton & crane sp17 dental chair when the chair became nonresponsive and then reclined back further. The dental hygienist then helped the patient out of the chair and asked if the patient was okay and the patient said he was. The dental hygienist then tried again to recline the patient in the dental chair and as the chair went back it tipped all the way back and appeared to have broken the linkage. The hygienist again helped the patient out of chair and the patient was ok. There were no injuries reported. The patient was moved to another operatory to perform the dental care.
Patient Sequence No: 1, Text Type: D, B5
[75957631]
The complete chair was returned to pelton and crane. Our initial evaluation indicated the truss assembly had failed which would be consistent with the reported complaint. However, upon further evaluation, it was identified that someone had modified the truss assembly by drilling and tapping 4 large holes into the truss assembly and had some type of unauthorized metal bracket attached to the chair utilizing these 4 holes which was located in the same area as the truss assembly failure. (b)(6) contacted the distributor with this information who then contacted the doctors office. During back and forth communication, pelton and crane was given conflicting and inconsistent information as to the purpose of these unauthorized 4 drilled and tapped large holes and attached bracket. The distributor informed pelton and crane that they were not involved with this modification and was unaware it took place as this was solely done by the dental office facility service department. As a result of this unknown and unauthorized modification, the root cause of failure is improper service by the end user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2017-00008 |
| MDR Report Key | 6358149 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-02 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2011-02-07 |
| Date Added to Maude | 2017-02-24 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | PELTON & CRANE |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIRIT 1700 CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2017-02-24 |
| Model Number | SP17 |
| Catalog Number | W1702 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |