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 2018-01-22 for SARA STEDY NTB2000 manufactured by Arjohuntleigh Magog Inc..
[98284283]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[98284284]
On 2018-jan-10 arjo was notified about event involving sara stedy active lift. It was reported that while patient was in the bathroom on the lift, the device moved forward into the wall. The lift brakes were locked. As a consequence the patient bumped her head on the wall. Based on the information in complaint record, the patient sustained a head bump. The patient was not taken to the emergency room and was not hospitalized. According to information provided by customer, the patient became very diaphoretic and was placed on the portable oxygen and then back in the bed. The patient showed scratches bilaterally on her shins, denied pain and stated that she bumped her head lightly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2018-00007 |
| MDR Report Key | 7209125 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-01-22 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-01-08 |
| Date Facility Aware | 2018-01-10 |
| Report Date | 2018-02-21 |
| Date Reported to FDA | 2018-02-21 |
| Date Reported to Mfgr | 2018-02-21 |
| Date Mfgr Received | 2018-01-10 |
| Date Added to Maude | 2018-01-22 |
| 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 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001 TANGUAY STREET |
| Manufacturer City | MAGOG, QUEBEC J1X 5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X 5Y5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA STEDY |
| Generic Name | CHAIR, WITH CASTERS |
| Product Code | INM |
| Date Received | 2018-01-22 |
| Model Number | NTB2000 |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Address | 2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5, CA J1X 5Y5, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-22 |