MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-10 for ENTROY GAB1000-01-GB manufactured by Arjo Hosp Equipment Ab.
[21333558]
Initially it was reported by arjohuntleigh rep that seat detached during use. The resident was lifted out of the pool on the entroy's chair. When the caregiver transferred the chair onto the chassis, the handle clicked in and showed green, then the chair including the base toppled over, including the base, with a resident in it, the chair came away from the base. Device condition has been described as satisfactory "for the age of machine". Function test performed with the customer showed that all functions were working ok on the device," especially the locking mechanism". The svc tech checked the chair unit on the entroy and the chair several times, each time this locked into place was designed. From this info we can state that the device met its spec. Arjohuntleigh's rep informed also about possibility of re-creating the reported event: "if the locking mechanism was in the read section, then the chair is able to swing out approx 45 degrees from the chassis and become very unstable and could easily topple over. " however this situation is outside the normal use of the device.
Patient Sequence No: 1, Text Type: D, B5
[21600930]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for entroy we have found a low number of other similar cases where seat or stretcher detached from entroy's lifting arm or base. Complaint rate concerning above reportable events is very low and decreasing. Please note that arjohuntleigh mfg about (b)(4) entroys to date. The device was inspected by an arjohuntleigh rep at the customer site and found to be to the spec - no fault was found. The device was being used for pt handling and in that way contributed to the event. The service tech checked the chair unit on the entroy and the chair several times, each time this locked into place as designed. From this info we can state that the device met its spec. Device examination did not reveal any malfunction that could have led to the reported event. As stated by the svc tech "all functions were working ok on the machine, especially the locking mechanism". From the rec'd info we can stat that the complained device met its spec. However further device examination showed that it was possible to re-create the reported incident: "chair is able to swing out approx 45 degrees from the chassis and become very unstable and could easily topple over". The svc tech made a comment regarding this situation where it was indicated that the problem is related to user error:"the only explanation that i can see for the chair to swivel 45 degrees from the chassis and also become detached from the chassis, is if the chair hadn't been locked onto the chassis during transfer". Info included in incident description form showed that the chair swivelled 45 degrees from the chassis and detached from it. The only explanation why this happened is incorrectly docked chair. This was also communicated by the svc tech as stated above. The most possible cause why chair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00056 |
| MDR Report Key | 4591513 |
| Report Source | 06,07 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-11 |
| Date of Event | 2014-12-22 |
| Date Facility Aware | 2015-02-11 |
| Date Reported to FDA | 2015-03-09 |
| Date Reported to Mfgr | 2015-03-09 |
| Date Mfgr Received | 2015-02-11 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2015-04-10 |
| 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 | PAMELA WRITE |
| Manufacturer Street | 12625 WETMORE STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| Manufacturer G1 | ARJO HOSP EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTROY |
| Product Code | FNG |
| Date Received | 2015-03-10 |
| Model Number | GAB1000-01-GB |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSP EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-10 |