MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-09-16 for MALIBU AZL23110-GB manufactured by Arjo Hospital Equipment Ab.
[54895317]
(b)(4). An investigation was carried out into this complaint. When reviewing reportable events for (b)(6), we have found limited number of other cases where the chair was not securely attached to the lifting arm. We have been able to establish that there is no complaint trend concerning this kind of events. Arjohuntleigh received customer complaint where it was reported that the resident had a bath several days before and two days later she claimed that she was injured by the bath lift arm dropping. The injury was described as bruising to the right hand side lower ribs, consulted with general practitioner. No treatment was applied. The nurses who were assisting the resident with that bathing session at the time were not aware of the chair lift dropping at any stage, also during and after the bathing session the resident did not mention or show any signs of discomfort or injury. It was confirmed that the resident was not left unattended at any time. Arjohuntleigh representative who performed device examination confirmed that the device was up to manufacturer specification. No repair or adjustment has been done. Product instruction for use, which is delivered with each device, includes information how to properly and safely use the device. It also includes warnings concerning the locking mechanism of the lifting unit, seat and transferring chair. From the interview it seems that all the guides and warnings included in the instruction for use were followed. What is worth to mention, "lift arm dropping", as claimed by the user, is very serious fault of this bath, and would be definitely noticed. More probable scenario of events (observed also in the previous complaints for malibu) would be detaching of the lift chair and patient's fall - however this was not confirmed by the staff assisting the bather. Arjohuntleigh representative, who went to the facility to gather all the information, discussed this matter with estate manager. They came to suspicion that the injuries were sustained elsewhere. In conclusion, no malfunction of the bath was found. It was used for patient's care and this way contributed to alleged event. Having that contradictory information we cannot confirm the event occurrence, establish exact scenario of events or root cause of the injury. Shall any additional information become available in the future, the investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10
[54895318]
Arjohuntleigh received customer complaint where it was reported that the resident had a bath several days before and two days later she claimed that she was injured by the bath lift arm dropping. The injury was described as bruising to the right hand side lower ribs, consulted with general practitioner. No treatment was applied. The nurses who were assisting the resident with that bathing session at the time were not aware of the chair lift dropping at any stage, also during and after the bathing session the resident did not mention or show any signs of discomfort or injury. It was confirmed that the resident was not left unattended at any time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2016-00196 |
| MDR Report Key | 5955442 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-17 |
| Date of Event | 2016-08-15 |
| Date Facility Aware | 2016-08-17 |
| Report Date | 2016-09-16 |
| Date Reported to FDA | 2016-09-16 |
| Date Reported to Mfgr | 2016-09-16 |
| Date Mfgr Received | 2016-08-17 |
| Device Manufacturer Date | 2010-11-11 |
| Date Added to Maude | 2016-09-16 |
| 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 | MRS. PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALIBU |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-09-16 |
| Model Number | AZL23110-GB |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-16 |