MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, MANUAL

Model Number P1190A000067

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The baxter technician found the hilo tower needed to be replaced.Per the hillrom service manual the advanta¿ 2 should be subject to an effective maintenance program.This will help make sure of a long, operative life for the advanta¿ 2 bed.The preventative maintenance will help to reduce downtime due to excessive wear failures.An annual service of the bed is advised in order to maintain its characteristics and performance.Examine the plug for damage.Make sure the plug is a one-piece molded plug assembly.If it is not, replace the plug cord assembly.Replace any plug cord assembly that shows any of these: discoloration of the plug molding around the plug blades; this could occur if the plug blades have overheated or arced.Any signs of cracking; this could occur if the plug has been bent and straightened to a point past its useful life.Loose fit of the plug blade (the plug blade moves in the molding); this could occur if the molding has overheated or the blades have been bent and straightened to a point past their useful life.Replace the power cord, if damaged.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the hilo tower to resolve the reported event.Based on this information, no further action is required.

Event Description

Baxter received a report from a baxter technician stating the bed hi/lo tower supply cable was cut with exposed copper wires.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Event Description

Baxter received a report from a baxter technician stating the bed hi/lo tower supply cable was cut with exposed copper wires.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

After further investigation, it was determined that there were no issues or physical damage of the power cord.The hilo tower supply assembly was replaced.The physical damage of cut bare wires was confirmed to be on a dc low voltage cable which is located inside the tower column located underneath the bed frame which would be inaccessible to the end user.Per hillrom service manual, hilo tower columns can be replaced in the event of a failure, but should never be dismantled or repaired except by hill-rom personnel.For the statements mentioned above, the reported event does not meet criteria of a reportable malfunction that could cause/contribute to a dsi if it were to recur.Reports of damaged or frayed low voltage components are not directly connected to the main power supply and are unlikely to cause or contribute to death or serious injury.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, MANUAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18438224
• MDR Text Key: 331829229
• Report Number: 3006697241-2024-00001
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P1190A000067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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