HILL-ROM RITTER

FDA MAUDE device safety record · 2002–2010

What the Data Shows About HILL-ROM RITTER

HILL-ROM RITTER is associated with 20,057 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2010. Of the total, 45 are coded as death reports and 104 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 14 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for HILL-ROM RITTER should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 19,468 reports (97.1% of total). Patient-outcome categorizations are reported across 7 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 9 years of MAUDE data, with the peak single-year volume reaching 8,180 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

20,057
Total Reports
45
Death Reports
104
Injury Reports
14
Device Types

Event Types

Malfunction 19,468 (97.1%)
Other 355 (1.8%)
Injury 104 (0.5%)
85 (0.4%)
Death 45 (0.2%)

Patient Outcomes

19,676 (98.1%)
Other 275 (1.4%)
Death 51 (0.3%)
Required Intervention 36 (0.2%)
Hospitalization 18 (0.1%)
Life Threatening 2 (0.0%)
R 1 (0.0%)

Yearly Trend

02
2002: 157
03
2003: 35
04
2004: 51
05
2005: 87
06
2006: 71
07
2007: 34
08
2008: 4,723
09
2009: 8,180
10
2010: 6,719

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.