MAUDE Adverse Event Report: HARD MFG. CO., INC. HARD; BED, PEDIATRIC OPEN HOSPITAL

Model Number PC1843-CGP

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

Event Date 09/03/2023

Event Type  malfunction  

Event Description

A hard mfg.Co.Pediatric crib with crib topper was utilized in the cardiovascular intensive care unit (cicu) and during the use of the device cardiopulmonary resuscitation, cpr+ mode was engaged.The system correctly activated cpr mode, however the device was difficult to administer cpr due to the topper blocking the doctor's access.A request was made to remove toppers for the device due to this design issue.

• Brand Name: HARD
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): HARD MFG. CO., INC.; 230 grider st; buffalo NY 14215
• MDR Report Key: 18208867
• MDR Text Key: 328999348
• Report Number: 18208867
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC1843-CGP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA