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 2019-03-14 for ROTOPRONE 209800 manufactured by Arjohuntleigh Inc..
[142626371]
(b)(4). Additional information will be provided upon conclusion of the investigation. It was reported by the customer that the buckle of the rotoprone bed fell apart while trying to open the buckle to release the patient, while device was placed in the supine position. The nurse decided to leave the patient in prone position until the arjo service technician arrival as the patient condition required it. In the complaint, the allegation was that the buckle fell apart while trying to release it and the nurses could not open it. When arjo service technician arrived to the facility, he noticed that red button on the buckle was missing. He was trying to open the buckle with the mechanism that was left but failed. Therefore, he decided to cut the strap to release the patient. The patient was transferred to a new bed. After the event, the rotoprone bed was returned to the service center. The buckle was replaced and the defective buckle was disposed of. It is worth pointing out that the buckles are used to restraining a patient on the rotoprone when the patient is in supine or prone therapy. User manual (#208662-ah rev. D), which is provided with each device, contains all crucial warnings, cautions and instruction. In the document, following information can be found: the instruction how the buckle should be fasten and unfasten, requirements of daily equipment instruction (including checking the appearance and functionality of the buckle). Rotoprone system was quality checked before being delivered to the customer; in this order, the asset was placed at the facility without defects. The involved in the event patient size was described as "small" and based on this information it can be assumed that the issue was not related to the buckle tension. After the event the buckle system was replaced. In conclusion, arjo rotoprone system played a role in the event as it was used for patient treatment and failed to perform as intended as buckle could not be opened. The incident was caused by the mechanical failure of the buckle (fail to meet manufacturer specification). It is unknown however why the buckle failed. There was no injury reported in relation to this event. We report this incident to the competent authority because of potential for health impact if it recurs.
Patient Sequence No: 1, Text Type: N, H10
[142626372]
It was reported by the customer that the buckle of the rotoprone bed fell apart while trying to open the buckle to release the patient, while device was placed in the supine position. The nurse decided to leave the patient in prone position until the arjo service technician arrival as the patient condition required it. In the complaint, the allegation was that the buckle fell apart while trying to release it and the nurses could not open it. When arjo service technician arrived to the facility, he noticed that red button on the buckle was missing. He was trying to open the buckle with the mechanism that was left but failed. Therefore, he decided to cut the strap to release the patient. The patient was transferred to a new bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00020 |
| MDR Report Key | 8419701 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-03-14 |
| 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 STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| 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 | 2019-03-14 |
| Model Number | 209800 |
| 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 | 2019-03-14 |