MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-09 for STEDY NTA1000 manufactured by Arjo Med. Ab Ltd.
[82677764]
(b)(4). (b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[82677765]
A customer reported that a female patient after delivery was transferred to the bathroom using a floor lift. At that moment it was stated that the patient condition was good. On a way back the patient lost consciousness while on steady and due to the fact that the seat section could not be lifted as a patient body weight lay on it, the patient had to be lifted over the device to place on a bed. While lifting the patient manually a caregiver felt pain in a back described as "zing". The caregiver returned to full duty, no medical intervention was required. Sudden weakness of a patient was caused by a "vasovagal response to her body adjusting to the bloodloss after childbirth. " there was not a serious injury in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2017-00059 |
| MDR Report Key | 6776353 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-07-07 |
| Date Facility Aware | 2017-07-11 |
| Report Date | 2017-08-28 |
| Date Reported to FDA | 2017-08-28 |
| Date Reported to Mfgr | 2017-08-28 |
| Date Mfgr Received | 2017-08-10 |
| Device Manufacturer Date | 2003-05-31 |
| Date Added to Maude | 2017-08-09 |
| 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 | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJO MED. AB LTD |
| Manufacturer Street | ST. CATHERINE ST. |
| Manufacturer City | GLOUCESTER, GL1 2SL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GL1 2SL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEDY |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2017-08-09 |
| Model Number | NTA1000 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO MED. AB LTD |
| Manufacturer Address | ST. CATHERINE ST. GLOUCESTER, GL1 2SL UK GL1 2SL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-09 |