MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. CAREVO

Model Number BAC1101-01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Bruise/Contusion (1754); Fall (1848); Head Injury (1879)

Event Date 03/04/2015

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

(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).

• Brand Name: CAREVO
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4742978
• MDR Text Key: 5770267
• Report Number: 3007420694-2015-00092
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/29/2015,03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BAC1101-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2015
• Distributor Facility Aware Date: 03/31/2015
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/29/2015
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 90