MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209800-R

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo received a call from the customer stating that they have issues with lower buckle.The buckle was jammed, so the staff was unable to release the male end.The customer stated that this issue was discovered when returning the patient to supine.Upon visiting the customer place, an arjo service team lead found the staff had disconnected the male portion of the buckle in order to open the lower pack.Both male and female buckles were replaced, and the patient was returned to further therapy.

Manufacturer Narrative

Investigation for this complaint was carried out.The conclusion is the following.Arjo received a call from the customer stating that they have issues with lower buckle.The buckle was jammed, so the staff was unable to release the male end.The customer stated that this issue was discovered when returning the patient to supine.An arjo technical reached the customer facility in order to solve the issue, finding that the staff had disconnected the male portion of the buckle.Both male and female buckles were replaced, and the patient was returned to further therapy.The photographic evidence provided shows the damaged buckle.In this image, it was possible to observe that the red button of the buckle was pressed down.It is unknown when and how the buckle became damaged.Rotoprone system is quality checked before being delivered to the customer.In this order, the asset was placed at the facility without defects.Product user manual (#208662-ah rev.D) includes the following information: - the instruction how the buckle should be fasten and unfasten, - requirements of daily equipment instruction (including checking the appearance and functionality of the buckle) when reviewing complaints for buckle inability to open due to mechanical failure, we have found two reportable cases (including the investigated here).There is no trend linked to this issue.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.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.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 8361097
• MDR Text Key: 136844949
• Report Number: 9681684-2019-00015
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other