MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-04-30 for CAREVO BAC1101-01 manufactured by Arjohuntleigh Polska Sp. Z.o.o..
[5770267]
Arjohuntleigh received a complaint where it was indicated that while the caregiver were attempting to shower the resident on the carevo shower trolley the safety side was not closed and the patient fell down on the floor.
Patient Sequence No: 1, Text Type: D, B5
[13259120]
(b)(4). When reviewing complaints for carevo brand name we found one other similar case where the caregiver did not close the safety side as it is obligated to do when using the carevo. There is no trend observed, complaint ratio is very low (0. 001) compared to the 1600 carevo devices currently on the market. Based on the technician evaluation, who checked the device after the incident and who confirmed that the involved carevo was in perfect condition with no fault found, we take the assumption that the device was working up to the manufacturer specifications at the time of the event, it was used for patient care at the time of the event and because of this contributed to the event. During the visit at the customer site, it was determined by the customer that when the caregiver placed the resident - who was paralyzed on one side - on the trolley had difficulties to put the resident's legs completely on the trolley as the patient's legs were stiff and heavy. Because the resident was not placed centrally on the device as required by the ifu procedures, and with the resident legs apparently not completely on the device, the caregiver could not close the safety side. The caregiver is indicated to have turned around and in this moment the patient dropped on the floor, according to the customer statement. The resident body fell following the legs dropping from the trolley. Therefore as stated by the customer facility also there appears to have been no technical deficiency with the device and that a use error caused the event, the most relevant use error being a failure of placing the resident on the middle of the trolley and not closing the safety sides after situating the resident on the device. From this we conclude that this incident was caused as a result of not following the handling procedures described in the device instructions for use (ifu). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00092 |
| MDR Report Key | 4742978 |
| Report Source | 05,06,07 |
| Date Received | 2015-04-30 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-04 |
| Date Facility Aware | 2015-03-31 |
| Report Date | 2015-04-29 |
| Date Reported to FDA | 2015-04-29 |
| Date Reported to Mfgr | 2015-04-29 |
| Date Mfgr Received | 2015-03-31 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-05-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z.O.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI 62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREVO |
| Product Code | FNG |
| Date Received | 2015-04-30 |
| Model Number | BAC1101-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z.O.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI 62052 PL 62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-04-30 |