BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAYSERBETT OLAF

    MDR report key: 24963101 · Received April 23, 2026

    Report

    Report Number
    3006795806-2026-00001
    Event Type
    Death
    Date Received
    April 23, 2026
    Date of Event
    November 17, 2023
    Report Date
    April 21, 2026
    Manufacturer
    KAYSERBETTEN GMBH & CO. KG
    Product Code
    FNL
    UDI-DI
    04260389610009
    Removal / Correction Number
    KB-806-IDA-2026-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: KAYSERBETT OLAF - MDR REPORT 3006795806-2026-00001. 1. UDI REGISTRATION (REFERENCE: SECTION D4). THE UDI SHOWN IN SECTION D4 IS THE GS1-COMPLIANT UDI-DI / UDI-PI ASSIGNED BY THE MANUFACTURER. - GUDID (FDA): THE UDI IS NOT CURRENTLY REGISTERED IN THE FDA GUDID DATABASE. THE KAYSERBETT OLAF MODEL IS NOT DISTRIBUTED IN THE UNITED STATES AND IS THEREFORE NOT SUBJECT TO GUDID REGISTRATION UNDER 21 CFR 830.320. - EUDAMED (EU): THE UDI IS NOT YET ENTERED IN EUDAMED. ENTRY IS PLANNED IN ACCORDANCE WITH EU MDR 2017/745 TIMELINES FOR THE UDI MODULE. PRODUCT DISTRIBUTION MODEL IN GERMANY: KAYSERBETT IDA/EMMA/OLAF ARE DISTRIBUTED AS SO-CALLED "KAUF-WIEDEREINSATZ" (PURCHASE-FOR-REASSIGNMENT) PRODUCTS. OWNERSHIP LIES WITH THE STATUTORY HEALTH INSURANCE PROVIDER (KRANKENKASSE). THE DEVICE IS PLACED WITH A PATIENT FOR AS LONG AS IT IS CLINICALLY NEEDED. ONCE THE PATIENT NO LONGER REQUIRES THE BED - EITHER DUE TO DEATH, CLINICAL IMPROVEMENT (CARE BED NO LONGER NEEDED), OR CLINICAL DETERIORATION (A DIFFERENT TYPE OF CARE BED IS NEEDED) - THE DEVICE IS RETURNED, REPROCESSED BY A MEDICAL SUPPLY COMPANY (SANITAETSHAUS), AND REASSIGNED TO THE NEXT PATIENT. CONSEQUENTLY, A SINGLE DEVICE TYPICALLY SERVES MULTIPLE PATIENTS OVER ITS SERVICE LIFE OF >= 7 YEARS. THE UNIT INVOLVED IN THIS EVENT HAD BEEN IN CONTINUOUS USE AT THE PATIENT'S HOME FOR APPROXIMATELY 24 MONTHS (DELIVERY (B)(6) 2021 - EVENT 17 NOVEMBER 2023). THIS IS CONSISTENT WITH H5 = NO (REUSABLE DEVICE) AND H8 = REUSE. 2. THIRD PARTY SERVICE (REFERENCE: SECTION D8 - ANSWER: UNKNOWN. OWNERSHIP AND SERVICE MODEL: THE KAYSERBETT OLAF CARE COT IS OWNED BY THE STATUTORY HEALTH INSURANCE FUND (KRANKENKASSE) UNDER THE GERMAN STATUTORY HEALTH INSURANCE SYSTEM (SGB V). IT WAS PROVIDED TO THE PATIENT'S HOME FOR PEDIATRIC HOME CARE VIA A MEDICAL SUPPLY DEALER (SANITAETSHAUS), WHICH ACTS AS A SERVICE PROVIDER UNDER CONTRACT WITH THE KRANKENKASSE. THE SANITAETSHAUS FORMALLY QUALIFIES AS A THIRD-PARTY SERVICER. MAINTENANCE FRAMEWORK: THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU) PRESCRIBE PERIODIC MAINTENANCE. THIS MAINTENANCE IS PERFORMED BY THE SANITAETSHAUS AND REIMBURSED BY THE KRANKENKASSE. THERE IS NO DIRECT CONTRACTUAL RELATIONSHIP BETWEEN THE MANUFACTURER (KAYSERBETTEN GMBH UND CO. KG) AND THE SANITAETSHAUS. RATIONALE FOR "UNKNOWN": THE MANUFACTURER HAS NO SERVICE RECORDS FOR THE INDIVIDUAL UNIT (SERIAL NUMBER (B)(6)) AND CANNOT CONFIRM WHETHER THE PRESCRIBED MAINTENANCE WAS ACTUALLY PERFORMED IN THE PERIOD PRECEDING THE INCIDENT. SECTION D8 WAS THEREFORE ANSWERED "UNKNOWN". 3. DEVICE AVAILABLE FOR EVALUATION (REFERENCE: SECTION D9 - YES). RETURN TO MANUFACTURER: THE DEVICE (SERIAL NUMBER (B)(6)) WAS RETURNED TO THE MANUFACTURER ON (B)(6) 2024 AND INSPECTED BY KAYSERBETTEN GMBH UND CO. KG. RESULT OF MANUFACTURER EVALUATION: TECHNICAL CONDITION: THE DEVICE WAS FOUND TO BE IN TECHNICALLY SOUND AND FULLY FUNCTIONAL CONDITION. NO TECHNICAL DEFECT, NO MECHANICAL FAILURE, AND NO MALFUNCTION OF THE ELECTRIC HEIGHT ADJUSTMENT OR THE HAND CONTROL WERE IDENTIFIED. ALL SAFETY-RELEVANT COMPONENTS WERE WITHIN SPECIFICATION. HYGIENIC CONDITION: THE DEVICE WAS RETURNED IN A HYGIENICALLY NOT FULLY CLEAN CONDITION. THIS OBSERVATION IS NOT RELATED TO THE INCIDENT AND DOES NOT AFFECT THE TECHNICAL SAFETY ASSESSMENT. 4. CONCOMITANT MEDICAL PRODUCTS (REFERENCE: SECTION D10). NO CONCOMITANT MEDICAL PRODUCTS OR THERAPIES CONTRIBUTED TO THE EVENT. THE INCIDENT WAS CAUSED BY AN ERROR IN USE IN THE OPERATION OF THE DEVICE (SEE SECTIONS B5, B7 AND COVER LETTER SECTION 3). DETAILED PATIENT THERAPY INFORMATION AT THE TIME OF THE INCIDENT IS NOT AVAILABLE TO THE MANUFACTURER. THE USER INCIDENT REPORT (ANWENDERMELDUNG) SUBMITTED BY THE SANITAETSHAUS TO BFARM, WHICH IS THE PRIMARY INFORMATION SOURCE, DOES NOT CONTAIN INFORMATION ON CONCOMITANT PRODUCTS. THE D10 FORM FIELD WAS POPULATED WITH A SHORT STATEMENT ("NOT APPLICABLE. NO CONCOMITANT THERAPIES.") DUE TO THE LIMITED CHARACTER COUNT AVAILABLE IN THAT FIELD. 5. INITIAL REPORTER (REFERENCE: SECTION E). IDENTIFICATION OF THE INITIAL REPORTER: THE INITIAL REPORTER IDENTIFIED IN SECTION E IS THE GERMAN FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES (BUNDESINSTITUT FUER ARZNEIMITTEL UND MEDIZINPRODUKTE, BFARM). BFARM IS A FEDERAL REGULATORY AUTHORITY AND THE DESIGNATED EU COMPETENT AUTHORITY UNDER EU MDR 2017/745. BFARM FORMALLY NOTIFIED THE MANUFACTURER BY EMAIL ON (B)(6) 2023, PROVIDING A COPY OF THE USER INCIDENT REPORT (ANWENDERMELDUNG) SUBMITTED BY THE (B)(4) ON (B)(6), 2023 (BFARM CASE NO. (B)(4), SEE COVER LETTER SECTION 5 AND APPENDIX 7). CONTACT NAME CONVENTION: IN LINE WITH STANDARD GERMAN ADMINISTRATIVE PRACTICE, BFARM SIGNS OFFICIAL CORRESPONDENCE WITH THE NAME OF THE RESPONSIBLE ORGANIZATIONAL UNIT ("ABTEILUNG MEDIZINPRODUKTE" / "MEDICAL DEVICES DEPARTMENT") RATHER THAN WITH THE NAME OF AN INDIVIDUAL OFFICER. THE CONTACT'S NAME FIELDS IN SECTION E1 ARE THEREFORE POPULATED WITH THE NAME OF THE ORGANIZATIONAL UNIT. OCCUPATION FIELD (E3): THE OCCUPATION FIELD IN SECTION E3 WAS SET TO "NON-HEALTHCARE PROFESSIONAL", BECAUSE THE MEDWATCH ESUBMITTER OCCUPATION DROPDOWN DOES NOT PROVIDE A CATEGORY SUCH AS "REGULATORY AUTHORITY" OR "GOVERNMENT OFFICIAL". THE SELECTION IS CONSISTENT WITH SECTION E2 (HEALTH PROFESSIONAL? = NO) AND ACCURATELY REFLECTS THAT BFARM IS A REGULATORY AUTHORITY AND NOT A HEALTHCARE PROVIDER. REGULATORY CLASSIFICATION OF THE DEVICE: THE SUSPECT DEVICE (KAYSERBETT OLAF) AND THE SIMILAR DEVICE MARKETED IN THE U.S. (KAYSERBETT IDA) ARE CLASSIFIED UNDER 21 CFR 880.5100 ("AC-POWERED ADJUSTABLE HOSPITAL BED"), PRODUCT CODE FNL ("BED, AC-POWERED ADJUSTABLE HOSPITAL"), DEVICE CLASS II (SPECIAL CONTROLS). 510(K) EXEMPTION STATUS: PER 21 CFR 880.5100(B): "CLASS II (SPECIAL CONTROLS). THE DEVICE IS EXEMPT FROM THE PREMARKET NOTIFICATION PROCEDURES IN SUBPART E OF PART 807 OF THIS CHAPTER SUBJECT TO SEC. 880.9." THIS EXEMPTION HAS BEEN IN PLACE SINCE 1998 (63 FR 59229, (B)(6) 1998). THE FDA PRODUCT CLASSIFICATION DATABASE CONFIRMS THE SUBMISSION TYPE FOR PRODUCT CODE FNL AS "510(K) EXEMPT". KAYSERBETTEN OPERATES UNDER THIS EXEMPTION AND COMPLIES WITH THE GENERAL LIMITATIONS OF 21 CFR 880.9. THE COMPANY IS PROPERLY REGISTERED WITH FDA AS A MANUFACTURER: - FDA ESTABLISHMENT REGISTRATION NO.: (B)(4). - OWNER/OPERATOR NO.: (B)(4). - ESTABLISHMENT OPERATIONS: MANUFACTURER. BOTH OLAF AND IDA ARE LISTED IN KAYSERBETTEN'S FDA DEVICE LISTING UNDER THE SAME PRODUCT CODE (FNL) AND REGULATION NUMBER (B)(4). CONSEQUENCE FOR THIS SUBMISSION: SECTION G4 (PMA/510(K) NUMBER) HAS BEEN LEFT BLANK. NO 510(K) CLEARANCE NUMBER IS APPLICABLE TO THIS SUBMISSION. ALL OTHER G4 SUB-FIELDS (NDA, ANDA, IND, BLA, COMBINATION PRODUCT, PRE-ANDA, PRE-1938, OTC, COMPOUNDED PRODUCT) AND SECTION G5 (IND/PRE-ANDA PROTOCOL NUMBER) ARE NOT APPLICABLE TO A DEVICE REPORT OF THIS TYPE AND HAVE ALSO BEEN LEFT BLANK. 7. CONCLUSION: THE MANUFACTURER EVALUATION CONFIRMS THE ROOT CAUSE ANALYSIS DOCUMENTED IN THE RISK ASSESSMENT (SEE COVER LETTER, SECTION 3): - THE INCIDENT IS ATTRIBUTABLE TO AN ERROR IN USE. - THE DEVICE DID NOT EXHIBIT ANY TECHNICAL MALFUNCTION. - NO CONTRIBUTING DESIGN FACTOR WAS IDENTIFIED IN THE INCIDENT ITSELF. NOTWITHSTANDING THE ABOVE, AND IN ACCORDANCE WITH ISO 14971, THE HAZARD SCENARIO HAS BEEN PROSPECTIVELY RECLASSIFIED AS A REASONABLY FORESEEABLE MISUSE. AS A PRECAUTIONARY MEASURE, A TECHNICAL CORRECTIVE ACTION (AUTO-LOCK HAND CONTROL) HAS BEEN IMPLEMENTED. SEE COVER LETTER SECTION 3 AND APPENDIX 5 (DESIGN CONTROL DOCUMENTATION) FOR DETAILS. END OF ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A FATAL ACCIDENT OCCURRED IN A HOME-CARE SETTING IN GERMANY INVOLVING A KAYSERBETT OLAF CARE COT (MANUFACTURER: KAYSERBETTEN GMBH & CO. KG; FDA ESTABLISHMENT REGISTRATION NO. (B)(4); PRODUCT CODE FNL; REGULATION NUMBER (B)(4)). SOURCE OF THE EVENT DESCRIPTION: THE FOLLOWING DESCRIPTION OF THE EVENT AND THE STATED CAUSE OF DEATH ARE TAKEN FROM THE OFFICIAL USER INCIDENT REPORT (ANWENDERMELDUNG) SUBMITTED BY THE MEDICAL SUPPLY DEALER (SANITAETSHAUS) TO THE GERMAN COMPETENT AUTHORITY (BFARM) UNDER THE EUROPEAN VIGILANCE SYSTEM AND ARE BASED ON THE STATEMENTS OF THE PATIENT'S FATHER. NO ADDITIONAL FINDINGS, IN PARTICULAR NO FORMAL MEDICAL CAUSE OF DEATH OR AUTOPSY RESULTS, HAVE BEEN COMMUNICATED TO THE MANUFACTURER BY THE INVESTIGATING AUTHORITIES. A SEVEN-YEAR-OLD BOY WAS BEING CARED FOR BY HIS GRANDMOTHER. THE GRANDMOTHER OPENED THE BED DOORS AND LEFT THE ROOM WITHOUT FIRST LOWERING THE SLEEPING PLATFORM TO ITS LOWEST POSITION AND LOCKING THE HAND CONTROL WITH A KEY. THE BOY CLIMBED OUT OF THE BED, CRAWLED UNDER THE SLEEPING PLATFORM, AND OPERATED THE HAND CONTROL HIMSELF. AS A RESULT, THE SLEEPING PLATFORM LOWERED, AND THE BOY BECAME STRANGLED BETWEEN THE SLEEPING PLATFORM AND THE LOWER FRAME OF THE BED. THE BOY DIED AS A RESULT OF THE STRANGULATION. RISK ASSESSMENT: THE INCIDENT WAS CAUSED BY FAILURE TO FOLLOW THE SAFETY INSTRUCTIONS DOCUMENTED IN THE USER MANUAL (LOCKING THE HAND CONTROL AFTER USE, LOWERING THE SLEEPING PLATFORM BEFORE LEAVING THE ROOM) AND IS ATTRIBUTABLE TO AN ERROR IN USE. THE KAYSERBETT OLAF CARE COT DID NOT EXHIBIT ANY TECHNICAL MALFUNCTION AT THE TIME OF THE INCIDENT. A RISK THAT WAS NOT FORESEEN AT THE TIME MATERIALIZED SOLELY AS A RESULT OF SEVERAL CUMULATIVE USER ERRORS. THE INCIDENT WAS REPORTED IN A TIMELY MANNER TO THE GERMAN COMPETENT AUTHORITY (BFARM). FOLLOWING CONSENSUS WITH BFARM AND THE REGIONAL REGULATORY AUTHORITY, THIS TYPE OF ERROR IS CLASSIFIED GOING FORWARD AS "REASONABLY FORESEEABLE MISUSE" UNDER ISO 14971. THIS RECLASSIFICATION REQUIRED A TECHNICAL CORRECTIVE ACTION. KAYSERBETTEN THEREFORE DEVELOPED, IN COOPERATION WITH ITS DRIVE MANUFACTURER, A MODIFIED HAND CONTROL WITH AN AUTO-LOCK FUNCTION AS A PRECAUTIONARY MEASURE TO ELIMINATE THIS MISUSE RISK IN THE FUTURE. A FIELD SAFETY CORRECTIVE ACTION IS IN PROGRESS FOR THE AFFECTED MODELS KAYSERBETT OLAF, IDA AND EMMA. THIS REPORT IS SUBMITTED UNDER 21 CFR PART 803 BECAUSE THE KAYSERBETT IDA CARE COT, WHICH IS ACTIVELY DISTRIBUTED IN THE UNITED STATES, IS A SIMILAR DEVICE WITHIN THE MEANING OF 21 CFR 803.50(A) AND IS LISTED IN THE SAME FDA DEVICE LISTING (PRODUCT CODE FNL, REGULATION (B)(4)). A COMPLETE DESCRIPTION OF THE EVENT, THE RISK ASSESSMENT, CORRECTIVE AND PREVENTIVE ACTIONS, AND THE U.S. FIELD ACTION IS PROVIDED IN THE ACCOMPANYING COVER LETTER AND APPENDICES 1 TO 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024925 KAYSERBETT OLAF PEDIATRIC HOSPITAL BED FNL KAYSERBETTEN GMBH & CO. KG OLAF 135 04260389610009

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Death NOT APPLICABLE. NO CONCOMITANT THERAPIES.