MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for SARA COMBILIZER APA1000-US manufactured by Arjohuntleigh Polska Sp Z O.o.
[142780964]
(b)(4). Additional information will be provided upon conclusions of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[142780965]
On 22 feb 2019 arjo was informed about the event, which occurred in (b)(6) hospital in the us. It was reported that during using arjo device- sara combilizer, the emergency lowering function did not work when the patient experienced shortness of breath and the resuscitation was needed. The resuscitation was performed in the standing position. After that, the patient was removed from the device. The patient did not sustain any injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00049 |
| MDR Report Key | 8435275 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-02-20 |
| Date Facility Aware | 2019-02-22 |
| Report Date | 2019-06-14 |
| Date Reported to FDA | 2019-06-14 |
| Date Reported to Mfgr | 2019-06-14 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2018-10-23 |
| Date Added to Maude | 2019-03-20 |
| 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 | KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Street | KS. 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 | 0 |
| Brand Name | SARA COMBILIZER |
| Generic Name | TABLE, POWERED |
| Product Code | INQ |
| Date Received | 2019-03-20 |
| Model Number | APA1000-US |
| Device Availability | * |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-20 |