Bed, manual: medical device reports filed with FDA

1,004 reports carry this product code, 1992–2026; 10 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,004
reports with this product code: 0% of all MAUDE reports; 115
reports, 12 months to August 2026: 53 in the 12 months before; 40.6%
classified as malfunction: 62.3% across all reports; 25%
classified as death, as reported: 0.9% across all reports

Product code FNJ is FDA's classification for "Bed, manual" (general Hospital panel), a class 1 device. 1,004 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

115 reports arrived in the 12 months to August 2026, up 117% from 53 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (40.6%), death (25%) and injury (18.3%). 10 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Advanta 2 Frame	78	0	0%	99.6%
Advanta 2 Bed	29	39	0%	94.7%
Hill-Rom	26	0	18.7%	31.1%
Invacare	15	0	17%	27%
Advanta Bed	4	5	0.3%	97.1%
Advanta	2	0	0%	90.3%
Cs Bed 9153650455	1	0	0.2%	99.4%
Guardian	1	350	0.4%	72.2%
Stryker	1	5	1.3%	46.3%
Trsx5/Wd08/Ad/28/34p/U240/1255/U2222/Ahdrm/9691b/Gvt93hc/G1360/Bh16 9153649403	1	0	0%	98.9%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Hill-Rom Mexico	107	10.7%
Hill-Rom	53	5.3%
Invacare	49	4.9%
Invacare Florida Operations	26	2.6%
Hill-Rom Ritter	14	1.4%
Carroll Healthcare	8	0.8%
J T Posey	7	0.7%
Medline Industries	6	0.6%
Stryker Medical Div	6	0.6%
Stryker Medical	5	0.5%
Stryker Medical London Chg Hospital Beds	4	0.4%
Invamex	3	0.3%
Kinetic Concepts	3	0.3%
Hill-Rom Batesville	2	0.2%
Arjo Hospital Equipment	1	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death25%251

Injury18.3%184

Malfunction40.6%408

Other13.4%135

Not given2.6%26

Who filed

Manufacturer report61.9%621

Voluntary report12.5%126

User facility report0%0

Distributor report1.7%17

Not given23.9%240

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Unintended movement	98	9.8%
Other (for use when an appropriate device code cannot be identified)	71	7.1%
Entrapment of device	68	6.8%
Side rails, failure of	52	5.2%
Breakthe device broke	50	5%
Collapse	45	4.5%
Design/structure problem	34	3.4%
Component falling	31	3.1%
Activation problem	29	2.9%
No audible alarm	26	2.6%
Component(s), broken	25	2.5%
Material split, cut or torn	25	2.5%
Detachment of device component	21	2.1%
Mechanical problema mechanical problem	19	1.9%
Bent	18	1.8%
Insufficient device problem information	14	1.4%
Mechanical jam	14	1.4%
Unstable	13	1.3%
Device slipped	12	1.2%
Fracturea broken bone	12	1.2%

Questions about bed, manual reports

What is product code FNJ?

FDA's classification code for "Bed, manual", class 1, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,004 reports through August 2026, 115 of them in the latest 12 months.

Which brands appear most often?

Advanta 2 Frame (78), Advanta 2 Bed (29), Hill-Rom (26), Invacare (15) and Advanta Bed (4). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.