BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS MODEL 90207 ABP MONITOR

    MDR report key: 5089504 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00016
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 28, 2020
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    DXN
    PMA / PMN Number
    K103732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVESTIGATION WAS CONDUCTED BY SPACELABS PRODUCT SUPPORT SPECIALISTS IN BOTH THE USA AND THE UK. THE BATTERY CONTACT SPRINGS WERE IN GOOD CONDITION WITH NO SHARP EDGES OR PROTRUSIONS. THE INSULATION ON THREE OF THE FOUR ENVELOPED RECHARGEABLE BATTERIES WAS CRINKLED, WHICH MAY HAVE BEEN CAUSED BY OVERHEATING. THE INSULATION WAS OTHERWISE UNDAMAGED, NO TEARS, OR PERFORATION. THE BATTERIES HAD THE NORMAL TERMINAL VOLTAGE OF 1.2V AND WERE NOT IN A STATE OF DEEP DISCHARGE. THE PRINTED CIRCUIT BOARD, AND INSIDE OF THE MONITOR REVEALED NO SIGNS OF OVERHEATING, EXCESSIVE CURRENT OR LIQUID INGRESS. THE MONITOR POWERED UP NORMALLY WITH NO ERRORS WHEN SUPPLIED FROM AN EXTERNAL POWER SUPPLY, (THE BATTERY COMPARTMENT WAS TOO SEVERELY DISTORTED TO USE WITH BATTERIES). THE DAMAGE IS CONSISTENT WITH A TEMPORARY SHORT CIRCUIT ACROSS AT LEAST THREE OF THE BATTERIES, BUT THERE IS INSUFFICIENT EVIDENCE TO DETERMINE ROOT CAUSE. THIS INVESTIGATION IS CONSIDERED COMPLETE, AND THE ISSUE CLOSED. THIS REPORT IS BEING GENERATED AT THE DIRECTION OF FDA BECAUSE OF SUPPLEMENTAL REPORTS RECEIVED, WITH THIS MANUFACTURER REPORT NUMBER, AND NO RECORD OF AN INITIAL REPORT.  THIS MANUFACTURER REPORT IS SUBMITTED TO CORRECT A PREVIOUS REPORT, 3010157426-2014-00115, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1, AND MISTAKENLY IDENTIFIED THE MANUFACTURER BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A PATIENT DROPPED AN AMBULATORY BLOOD PRESSURE (ABP) MONITOR MODEL#: 90207-32 DURING AN OVERNIGHT OBSERVED STUDY, PICKED UP THE MONITOR AND PLACED IT UNDER HIS PILLOW TO CONTINUE DATA COLLECTION. LATER THE SAME NIGHT, THE UNIT BECAME VERY HOT AND EMITTED A BAD SMELL. THE PATIENT INFORMED THE NURSE. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620664 SPACELABS MODEL 90207 ABP MONITOR ABP MONITOR DXN SPACELABS HEALTHCARE LTD. 90207

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female