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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; TABLE, OBSTETRIC
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HILL-ROM BATESVILLE AFFINITY 4 BED FRAME; TABLE, OBSTETRIC Back to Search Results
Model Number P3700D000037
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 12/06/2020
Event Type  malfunction  
Manufacturer Narrative
The hillrom technician found the brake detent needed to be replaced.Per the hillrom service manual the affinity® three birthing bed and affinity® four birthing beds require an effective maintenance program.We recommend that you perform semiannual preventive maintenance.Check the tires for cuts, wear, tread life, etc.Apply the brake, and check to ensure that the bed will not move.If the bed moves, inspect it for wear, and adjust if required.Apply the steering pedal and check the steering to ensure proper locking action when activated.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the brake detent to resolve the issue.Based on this information, no further action is required.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed brakes were not holding.The bed was located in biomed at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #1320245.
 
Manufacturer Narrative
Further investigation showed that the incorrect aware date was selected when original allegation was reported to hillrom.This follow-up mdr is being submitted to reflect the correct awareness date of december 6, 2020.Reference original mdr submitted on december 10, 2020.
 
Event Description
Hillrom received a report from a hillrom technician stating the bed brakes were not holding.The bed was located in biomed at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand Name
AFFINITY 4 BED FRAME
Type of Device
TABLE, OBSTETRIC
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
emily mitchell
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key10984557
MDR Text Key221296725
Report Number1824206-2020-00512
Device Sequence Number1
Product Code KNC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP3700D000037
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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