MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for ALLEN LIFT ASSIST BEACH CHAIR A-91501-A1 manufactured by Allen Medical Systems.
[131381345]
Hill-rom's initial investigation revealed there was insufficient loctite applied where the top hydraulic assembly connects to the supporting tubes of the backboard of the chair. If this joint loses connection, the force would be directed onto the backboard of the chair which may cause it to sheer apart as it appears occurred in this incident. No further information is available on the repair of the chair at this time. Hill-rom has initiated a capa to further investigate this incident and the investigation is ongoing. If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[131381346]
Hill-rom received a report from the account stating the beach chair fell back during a procedure. The momentum was minimized by a pump next to the patient and a staff member who held the chair in the upright position the surgeon finished the procedure and no patient/user injury was reported. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010216206-2018-00002 |
| MDR Report Key | 8185431 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN DRAHOS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALLEN LIFT ASSIST BEACH CHAIR |
| Generic Name | BEACH CHAIR |
| Product Code | CCX |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-12-11 |
| Model Number | A-91501-A1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | 100 DISCOVERY WAY ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |