MAUDE Adverse Event Report: AGILITI HEALTH - ELLIS PULSATE BLOWER ASSEMBLY; MATTRESS CONTROL UNIT

Lot Number 31561

Device Problem Connection Problem (2900)

Patient Problem Electric Shock (2554)

Event Date 09/19/2023

Event Type  Injury  

Event Description

An employee of piedmont or patient or patient family member in some way pulled the receptacle that is attached to the blower by two rivets.This receptacle was pulled out and pulled away from the three wires connected into the back of it.The individual who did this then draped the broken end of the cord over the head of the head of the bed and left it there.At some point later a nurse came as the mattress was not inflating because the cord and receptacles had been pulled out of the blower.When the nurse grabbed the cord because it was still plugged in to the wall it sparked and there was a pop.While no patient injury occurred, the potential for serious injury necessitates reporting this incident to the fda.

• Brand Name: PULSATE BLOWER ASSEMBLY
• Type of Device: MATTRESS CONTROL UNIT
• Manufacturer (Section D): AGILITI HEALTH - ELLIS; 204 w 2nd st; ellis KS 67637
• Manufacturer (Section G): AGILITI HEALTH - ELLIS; 204 w 2nd st; ellis KS 67637
• Manufacturer Contact: jorge castro ; 204 w 2nd st; ellis, KS 67601 ; 8008149389
• MDR Report Key: 18370311
• MDR Text Key: 331048150
• Report Number: 3002693132-2023-70002
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 31561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1