MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for JAY BACK JAY BASIC BACK manufactured by Sunrise Medical Technologias.
[136114974]
The jay basic back was installed on a competitor's 20" lightweight drive cruiser chair. The dealer stated the metal brackets on the jay basic back are bent and threading is worn down. She states that one is still attached to chair, but there are missing parts on the back. The dealer returned the jay basic back to sunrise medical and it was received on 1/30/2019. The back was inspected and evaluated by quality manager, (b)(4), that same day. The following are findings from that evaluation: evaluation: the inspection confirms that components are missing as not all parts, such as clamps and brackets were not returned. The brackets show excessive wearing of the coating. The holes where the mounting screws fasten to, are stripped. Sunrise medical manufacturing does not adjust these screws in order to allow dealers to position the back on the chair and make adjustments as needed. The remaining screws that are on the back are overtightened. The torque is greater than the recommended torque specification of 15-20 in-lbs. , as stated on page 6, section c of the jay basic back owner's manual. The upper brackets are incorrectly twisted downward in their assembly. This can cause stress in the receiver. These brackets are width adjustable and would have been adjusted by the user/dealer when the back was mounted onto the chair. Conclusion: based on the findings from the evaluation, sunrise medical has concluded that the failure was due to incorrect installation of the back by the dealer or the end user. There was no malfunction or defect found. This issue/incident is under further investigation by sunrise medical's legal team as the dealer has advised that the end user has sought legal counsel for this incident. No further investigation will be performed by sunrise medical's ra/qa team at this time.
Patient Sequence No: 1, Text Type: N, H10
[136114975]
Per the dealer, (b)(4), daughter of patient was transferring patient from shower to chair when back came loose and patient fell and broke hip. (b)(4) states the end user was discharged from hospital on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616084-2019-00003 |
| MDR Report Key | 8337805 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-12 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2018-10-11 |
| Date Added to Maude | 2019-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GUSTAVO ZAMBRANO |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JAY BACK |
| Generic Name | JAY BASIC BACK |
| Product Code | IMP |
| Date Received | 2019-02-13 |
| Model Number | JAY BASIC BACK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNRISE MEDICAL TECHNOLOGIAS |
| Manufacturer Address | NO. 110 PARQUE INDUSTRIAL MISIONES DE LAS CALIFORNIAS TIJUANA, BAJA CALIFORNIA 22425 MX 22425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-13 |