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 2019-02-22 for ROTOPRONE 209500 manufactured by Arjohuntleigh, Inc..
[141194987]
(b)(4). Investigation was carried out to this incident and the conclusions are following. On (b)(6) 2019 arjo was informed about an incident with rotoprone system. It was stated that the proning pack buckle would not release. The attempt to open the buckle was not effective. The nurse left the patient in proning position until service technician arrival. An arjo service consultant who went to the facility to assist with the issue, was managed to open the proning packs by cutting the buckle straps. He confirmed also that the inability to open the buckle was related to the cloth that had stuck into the buckling mechanism. He stated that it appeared that the patient was very large and the pronging pack might be strapped so tight, that the material from the pronging pack was partially imbedded in the buckle. There were no damages to the side pack. In summary, the arjo device played a role in the event as it was used for patient treatment. The bed failed to perform as intended as buckle could not release when buckle release mechanism was pressed. There was no injury reported in relation to this event. We report this incident to the competent authority because of potential for serious injury or death if it recurs.
Patient Sequence No: 1, Text Type: N, H10
[141194988]
Arjo was informed about an incident with rotoprone system. It was stated that the proning pack buckle would not release. The attempt to open the buckle was not effective. An arjo service consultant who went to the facility to assist with the issue, was managed to open the packs by cutting the strap. A buckle was replaced. A service consultant confirmed that the inability to open the buckle was related to the cloth that had stuck into the buckle. There were no damages to the proning pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00016 |
| MDR Report Key | 8361084 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-01-24 |
| Date Added to Maude | 2019-02-22 |
| 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 | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJOHUNTLEIGH, INC. |
| Manufacturer Street | 4958 STOUT DRIVE |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78219 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTOPRONE |
| Generic Name | BED, PATIENT ROTATION, POWERED |
| Product Code | IKZ |
| Date Received | 2019-02-22 |
| Model Number | 209500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, INC. |
| Manufacturer Address | 4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-22 |