MAUDE Adverse Event Report: HILL-ROM, INC. CENTRELLA WITH WATCHCARE; ALARM, CONDITIONED RESPONSE ENURESIS

Catalog Number B7900B

Device Problem Device-Device Incompatibility (2919)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

Interference from new hill rom bed watchcare incontinence management system causing spikes in patient ecg in new ge carescape telemetry system.Hillrom deactivated watchcare system in all new beds problem not corrected yet.Fda safety report id# (b)(4).

• Brand Name: CENTRELLA WITH WATCHCARE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 15588249
• MDR Text Key: 301669701
• Report Number: MW5112537
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/06/2022

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 Catalogue Number: B7900B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose