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 2017-08-07 for SYSTEM 2000 manufactured by Arjo Hospital Equipment Ab.
[81904056]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4). As of 2014 that number was de-activated due to the site no longer shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[81904057]
Arjohuntleigh has received a customer complaint where it was reported that when the staff members were raising the lift with the resident in the sling the tub suddenly lowered lifting the support leg of the bath which afterwards landed on the caregiver's foot. As a result of the incident the patient sustained soft tissue damage to left foot. Caregiver is wearing a aircast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00171 |
| MDR Report Key | 6770072 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-08-07 |
| Date of Report | 2017-09-04 |
| Date of Event | 2017-07-29 |
| Date Facility Aware | 2017-07-31 |
| Report Date | 2017-09-04 |
| Date Reported to FDA | 2017-09-04 |
| Date Reported to Mfgr | 2017-09-04 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-08-07 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2017-08-07 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | DA |
| 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. Hospitalization | 2017-08-07 |