MAUDE Adverse Event Report: ARJO / ARJOHUNTLEIGH POLSKA SP. ZO.O. ARJO ROTOPRONE BED; BED, PATIENT ROTATION, POWERED

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2020

Event Type  malfunction  

Event Description

Rotoprone bed failed - no power.Required manual turning of bed.

Event Description

Additional information received on 6/12/2020 from reporter for report mw5094974.Rotoprone bed lost power, could not power on.Required manual turning of bed.

• Brand Name: ARJO ROTOPRONE BED
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJO / ARJOHUNTLEIGH POLSKA SP. ZO.O.
• MDR Report Key: 10148402
• MDR Text Key: 195002304
• Report Number: MW5094974
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 85